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| Catalog Number H470045A |
| Device Problem
Device Operates Differently Than Expected (2913)
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| Patient Problems
Death (1802); Hemorrhage/Bleeding (1888); Collapse (2416); Loss of consciousness (2418); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/03/2014 |
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Event Type
Death
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Manufacturer Narrative
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"gore tex® vascular graft" was selected as a default device as the patient alleged to have been implanted with a gore device that ¿was used.For the purpose of regular dialysis treatment.¿ product identification records for the alleged gore device were not provided but were requested.Initial reporter's complete address - (b)(6).A review of the manufacturing records could not be performed as the lot number of the alleged gore device was not provided.Udi is also unknown as no lot number was provided.Although it is unknown whether a gore device was involved, the gore tex® vascular graft instructions for use provides the following: "complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/ or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.".
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Event Description
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It was reported to gore that a patient alleges to have been implanted with a gore device that ¿was used in a normal and foreseeable manner by plaintiff for the purpose of regular dialysis treatment.¿ product identification and lot number of the alleged gore device was not provided.Lawsuit also names another device manufacturer and involvement of a gore device is not known.The complaint alleges that on (b)(6) 2014, ¿decedent was at home preparing for the day, including a scheduled dialysis treatment visits [sic], when the subject medical device implanted in her left arm failed, causing decedent to bleed out profusely from the location of the subject medical device.That as a result of the major blood loss caused by the medical device¿s failure, decedent lost consciousness and collapsed to the ground in her home.Further, that decedent never regained consciousness and, ultimately, succumbed to her injuries.The complaint states the cause of death to be ¿as a result of failure of a hemodialysis shunt.¿ additional, event specific information was not provided.Medical records have been requested.
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Manufacturer Narrative
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Concomitant medical products - insulin, coreg, diovan, aspirin, lipitor, reglan, lasix, zemplar.Added information from provided medical records.Conclusion code remains unchanged.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: medical records dated (b)(6) 2010 indicate a medical history of hypertension, insulin-dependent diabetes, anemia of chronic disease, hyperlipidemia, stage v kidney disease secondary to diabetic nephropathy, proteinuria.Past surgical history is noted as ¿cardiac stent put in.When she was in mountainview hospital, she had permcath put in.She had av gore-tex graft done in the left forearm by dr.Eddy luh, which is functioning well.¿ plan notes regarding the alleged gore device state: ¿the patient will continue hemodialysis treatment.Hopefully in a week or two, the patient¿s av gore-tex graft will be ready for hemodialysis treatment.¿ product identification records or an operative report of the implant of the alleged ¿av gore-tex graft¿ was not provided.Medical records between (b)(6) 2010 and (b)(6) 2014 were not provided.A coroner¿s summary of investigation report dated (b)(6) 2014 states: ¿possible accidental death via fistula burst in left arm.Dialysis patient.¿ ¿circumstances of death¿they [sic] decedent had been having dialysis treatments 3 times a week for the last 3 to 3 ½ years.The decedent¿s daughter¿stated that the decedent was fine last night, (b)(6) 2014.¿ ¿the decedent had taken her insulin as usual and did not have any health complaints.¿ ¿the decedent normally wakes up on dialysis treatment days at approximately 0300 hours.¿ ¿the decedent suddenly then walked from her bedroom, past her sister, to the bathroom.Her sister said something to her, but the decedent did not respond to her.Within just a few moments, the decedent suddenly collapsed in the bathroom¿.She was not responding.¿ ¿the family noticed blood starting to pool around the decedent.¿ ¿as they repositioned the decedent, blood was spurting from her arm.Paramedics arrived quickly and they started cardiopulmonary resuscitation.They transported the decedent to (b)(6) hospital, emergency room (er), arriving at approximately 0455 hours.All life saving measures were attempted till the decedent was pronounced at 0527 hours by dr.(b)(6).¿ the (b)(6) 2014 coroner¿s summary of investigation report states: ¿medical history: ¿the decedent was an insulin dependent diabetic and was on dialysis.She had broken her foot by twisting it wrong approximately 6 years ago.The decedent had off and on swelling with infection since then.The decedent was scheduled to see her foot doctor later today, (b)(6) 2014.She had stent placement approximately 5-6 years ago.They [sic] did not have any other known health problems.¿ ¿per the decedent¿s daughter, the decedent took blood pressure medication, insulin twice a day, and another unknown medication.¿ the (b)(6) 2014 coroner¿s summary of investigation report further states: ¿the decedent¿s sister¿found a tissue in the bedroom with apparent blood on it.She did not know if the decedent may have started bleeding in the bedroom and then went into the bathroom.Per family, the decedent did not have any history of having any difficulty with her dialysis or bleeding.¿ per the coroner, ¿the decedent had a large amount of apparent dried blood noted to her arms and legs.There was a black tourniquet tightly around the decedent¿s upper left arm.An open wound was noted to the decedent¿s left upper arm, above the elbow.¿ an autopsy report dated (b)(6) 2014 notes the following pathologic findings: ¿i.Failure of hemodialysis shunt, left upper arm.Ii.History of dialysis-dependent renal failure.Iii.Cardiomegaly (590 grams) with severe multi-vessel coronary artery atherosclerosis.Iv.Morbid obesity.¿ ¿cause of death: it is my opinion that this (b)(6)¿.Died as a result of failure of hemodialysis shunt.Manner of death: accident.¿ the (b)(6) 2014 autopsy report states: ¿evidence of injury: on the anterior left mid biceps region is a circular 2 mm defect in the skin with a surrounding rim of hyperemia which is up to 5 mm in maximum dimension.There is some adherent blood on the marginating skin.Dissection of the underlying soft tissue reveals a dialysis shunt immediately beneath the skin defect.The shunt itself contains a 2 mm perforating defect.¿ although it is unknown whether a gore device was involved, the gore tex® vascular graft instructions for use provides the following: "complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/ or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.".
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Manufacturer Narrative
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Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2010 indicate the patient was admitted to the hospital for elevated potassium.During this admission a temporary dialysis catheter was placed for dialysis.Records dated (b)(6) 2010 state a surgery consultation was performed to discuss long-term dialysis access.Operative records dated (b)(6) 2010 state the patient underwent ¿insertion left forearm brachial artery cephalic vein 4 to 7 mm taper av graft¿ for a diagnosis of end-stage renal disease.The records state: ¿an antecubital fossa incision was made.There was no definable size cephalic vein that went into the upper extremity; however, the antecubital vein was draining to a large basilic vein.Therefore, a subcutaneous tunnel was made two thirds of the way down the patient¿s forearm where a 4 to 7 mm taper av graft was placed.The 4 mm end was on the arterial ulnar side.The 7 mm end was on the venous radial side.Heparin 2500 units were given systemically.After full heparinization, a small venotomy was made and elongated with potts scissors.The graft was a spatulated end-to-side anastomosis with cv6 gore-tex suture.The graft was retrograde flushed and antegrade flushed and was clamped.Attention was turned to the artery where a small arteriotomy was made in the graft.The 4 mm end was sewn with cv6 gore-tex suture.Palpable thrill augmented on distal occlusion.Hemostasis was achieved with assistance of floseal.Palpable radial pulse.The wound was irrigated and closed with #2-0 pds, #3-0 monocryl, and dermabond.No complications.¿ the records confirm a gore propaten® vascular graft (h470045a/3281153pp010) was implanted.Medical records dated (b)(6) 2010 indicates the patient was seen with complaints of a cough.Medical history is noted as hypertension, insulin-dependent diabetes, anemia of chronic disease, hyperlipidemia, stage v kidney disease secondary to diabetic nephropathy, proteinuria.Past surgical history states: ¿cardiac stent put in.When she was in (b)(6) hospital, she had permcath put in.She had av gore-tex graft done in the left forearm by dr.(b)(6), which is functioning well.¿ plan notes regarding the alleged gore device state: ¿the patient will continue hemodialysis treatment.Hopefully in a week or two, the patient¿s av gore-tex graft will be ready for hemodialysis treatment.¿ medical records dated (b)(6) 2010 state the patient was seen for a postsurgical exam from her recent insertion of a left forearm av graft.¿hemodialysis sites: hemodialysis catheter graft on the left arm showed a thrill was present.Hemodialysis catheter graft on the left arm showed a bruit was present.Inquiry/incision site: well-healed incision along the left forearm.¿ ¿assessment: end stage renal disease with recent insertion of left forearm avg that is demonstrating a great thrill and bruit.It should work fine at dialysis once the wound heals.¿ therapy: authorization given for hemodialysis accessed by an arteriovenous graft in the left arm, (b)(6) 2011.Medical records dated (b)(6) 2011 state the patient was seen for a postsurgical exam regarding her av graft.¿she says that the graft stopped working earlier this week.It was working fine previously.¿ ¿hemodialysis sites: hemodialysis catheter graft on the left arm showed a thrill was absent.Hemodialysis catheter graft on the left arm showed a bruit was absent.Inquiry/incision site: well-healed incision along the left forearm.¿ ¿assessment: end stage renal disease with recent insertion of left forearm avg that was working fine until earlier this week.At the present time there is no evidence of a thrill or bruit identified in the left forearm av graft.It is recommended she proceed with surgical thrombectomy and possible revision.¿ medical records dated (b)(6) 2011 state the patient was again seen for a postsurgical exam from the recent revision of her left arm av graft.¿at this time the graft is functioning without incident and she presents today for removal of the indwelling chest catheter.¿ the records state ¿thrombectomy of av fistula (b)(6) 2011 of the left forearm av graft.¿ ¿hemodialysis sites: hemodialysis catheter graft on the left arm showed a thrill was present.Hemodialysis catheter graft on the left arm showed a bruit was present.Inquiry/incision site: well-healed incision along the left forearm.¿ ¿assessment: end stage renal disease with recent revision of the left arm av graft.She presents today for removal of the chest catheter.The forearm graft is functioning without incident.¿ operative records for the (b)(6) 2011 thrombectomy were not provided.Medical records dated (b)(6) 2011 state the patient was seen for a ¿postsurgical exam from recent insertion of left forearm avg.She subsequently had the catheter removed but the left forearm graft clot [sic].Patient went to access center would be graft [sic] was successfully opened with the assistance of a angioplasty of the venous outflow anastomosis.Additionally has had a temporary catheter placed back in the right chest.¿ ¿hemodialysis sites: hemodialysis catheter graft on the left arm showed a thrill was absent.Hemodialysis catheter graft on the left arm showed a bruit was absent.Inquiry/incision site: well-healed incision along the left forearm.¿ ¿assessment: end stage renal disease with recent insertion of left forearm avg that is working fine with recent lysis of the av graft and venous outflow anastomosis angioplasty.This was done at access center.Recommended allowing radiology to continue to using [sic] the graft for the next 2 weeks before considering removal of the indwelling catheter.¿ discharge summary records dated (b)(6) 2011 indicate the patient was seen in the emergency department for ¿bleeding from the site of [her] new dialysis catheter.¿ the records indicate pressure dressings were applied and the patient was discharged.Operative records dated (b)(6) 2011 state the patient underwent ¿1.Revision of left forearm arteriovenous graft without thrombectomy.2.Explore brachial artery.¿ post-operative diagnosis states: ¿clotted left forearm arteriovenous graft.¿ operative findings state: ¿the antecubital veins and the proximal brachial vein and basilic vein in the region of the antecubital fossa were all occluded without any evidence of significant outflow to revise the outflow anastomosis of the indwelling forearm av graft.¿ the (b)(6) 2011 operative report states: ¿the antecubital fossa incision was reentered and vessel control was obtained around the outflow limb of the av graft and the antecubital vein.Then, 1500 units of heparin was given systematically.After full heparinization, a graftotomy was made, elongated with potts scissors.The outflow antecubital vein could not be flushed with heparinized saline.Despite multiple passes of the fogarty catheter, there appeared to be some blockage just in the distal upper arm.Another incision was made in the medial upper arm to gain access to the basilic vein.However, the basilic vein was diminutive in size.After identifying the brachial artery, there was no significant size brachial vein that i thought would be amenable to outflow anastomosis.Therefore, because of this and concern of making additional unnecessary incision on the patient¿s arm, decision was made to irrigate both wounds, oversew the graft with silk ligature, oversew the outflow antecubital vein with a silk ligature.Hemostasis achieved with assistance of surgiflo.The wound was then closed with 2-0 pds, 3-0 monocryl.Palpable radial pulse of the wrist.No complications.¿ records dated (b)(6) 2011 indicate a venous doppler duplex color-flow ultrasound of the extremities was performed for ¿preoperative vein mapping¿.For possible dialysis access placement.¿ findings from the ultrasound state: ¿findings demonstrate neither cephalic vein suitable for both forearm and upper arm fistula creation bilaterally.Findings demonstrate neither basilic vein suitable for transposition fistula in upper arm bilaterally.¿ medical records dated (b)(6) 2011 state the patient was seen for follow up following ¿recent attempt at salvage of the left forearm av graft.Unfortunately at the time of surgery there was no outflow vein amenable to extension of the graft.She was brought back to reevaluate the arm vein mapping for consideration of new access placement¿¿ the records state: ¿hemodialysis sites: "hemodialysis catheter graft on the left arm showed a thrill was absent.Hemodialysis catheter graft on the left arm showed a bruit was absent.Injury/ incision site: well-healed incision along the left forearm.¿ ¿assessment: end stage renal disease with recent unsuccessful salvage of the left forearm av graft.An updated vein mapping identifies no vessels in either extremity amenable to fistula creation.Therefore at this time have recommended and she agrees to proceeding with insertion of a left upper arm av graft.¿ medical records dated (b)(6) 2011 state the patient was seen for follow up regarding lab results.¿the patient feels well with no complaints, has good energy and is sleeping well.¿ ¿(b)(6) female with end stage renal [disease] on dialysis, recently hospitalized for clotted renal shunt.Now being dialyzing through temporary line.¿ discharge summary records dated (b)(6) 2011 indicate the patient was seen in the emergency department for ¿dialysis shunt-av graft bleeding.¿ operative records dated (b)(6) 2011 indicate the patient underwent ¿insertion left upper arm av graft 4 to 7 mm taper.¿ the records state: ¿a left axillary incision made.The vessel was controlled and, around the axillary vein, an antecubital fossa and vessel control was seen around the brachial artery.A subcutaneous tunnel was made and 3000 units of heparin were given systematically.After full heparinization, a 4 to 7 mm taper av graft was passed through this tunnel.A 7 mm.End is spatulated in an end-to-end anastomosis to a venotomy up in the axilla with cv-6 gore tex suture.Retrograde flushed, antegrade flushed and clamped.A 4 mm end was sewn flush to the brachial artery with a cv 6 gore-tex suture.Palpable thrill, palpable radial pulse at the level of the wrist.Wound was irrigated and made hemostatic with floseal, closed with [illegible] pds and metal [illegible] clips.No complications.¿ product identification records for the ¿4 to 7 mm taper av graft¿ implanted on (b)(6) 2011 were not provided.It is unclear from the records if the existing gore propaten® vascular graft was removed during the procedure.Medical records dated (b)(6) 2011 state the patient was seen for postsurgical follow up ¿from recent insertion of left upper arm av graft¿¿ ¿hemodialysis sites: hemodialysis catheter graft on the left arm showed a thrill was present.Hemodialysis catheter graft on the left arm showed a bruit was present.Injury/ incision site: well-healed incision along the left forearm.¿ ¿assessment: end stage renal disease with recent insertion of left upper arm av graft.There is a strong thrill throughout the entire graft.Staples removed at the bedside authorization is given to use this graft for dialysis starting next week.Followup in 2-3 weeks time for consideration of catheter removal.¿ medical records dated (b)(6) 2011 state the patient was seen for follow up.¿the patient feels well with no complaints, has good energy and is sleeping well.¿ ¿¿had new fistula inserted left upper arm.¿ records dated (b)(6) 2011 state the patient was again seen for follow up, which showed ¿hemodialysis catheter graft on the left arm showed a thrill was present.Hemodialysis catheter graft on the left arm showed a bruit was present.¿ ¿assessment: there is a strong thrill throughout the entire graft.At this time will plan for removal of the indwelling catheter.However patient is on both plavix and aspirin and will request that she stop her aspirin for one week prior to catheter removal.¿ records dated (b)(6) 2011 state the patient was again seen for follow up, which showed ¿hemodialysis catheter graft on the left arm showed a thrill was present.Hemodialysis catheter graft on the left arm showed a bruit was present.¿ ¿assessment: there is a strong thrill throughout the entire graft.At this time will remove the indwelling catheter today.¿ records between (b)(6) 2011 and (b)(6) 2014 and relating to the investigation were not provided.Dialysis records from (b)(6) 2013 to (b)(6) 2014 state: ¿type: av graft ¿ unknown.Site: above elbow-left.Status: active.¿ ¿vascular access: vascular access reviewed.Current access is permanent and functioning well.¿ ¿patient is doing well and has no complaints.¿ records dated (b)(6) 2014 indicate the patient was seen during a follow up visit and had complaints of generalized itching visit to er with a possible dermatology referral.Dialysis records dated (b)(6) 2014 state: ¿access noted, redness to the area, [patient] states may have scratch area.No drainage noted.¿ dialysis records dated (b)(6) 2014 state: ¿¿.Noted irritation to access site redness, noted drainage, no odor noted, denies pain, swab done, afebrile, dressing done.Dr.(b)(6) informed.Blood culture x2 as order done, swab stick to drainage, dr.(b)(6) informed.[patient] as well complaining of itchiness, req.Prn benadryl, given as order.[patient] taking po meds for itchiness as home.[patient] verbalized ¿its not as bad as before.¿¿ medical records dated (b)(6) 2014 state: ¿(b)(6) 2014 [patient] had redness over av fistula with drainage on (b)(6) 2014.Blood [culture/sensitivity] done: iv vancomycin 1gm started times 6dose until [culture/sensitivity] reports available.On (b)(6) 2014 [patient[ has been hypotensive during hd, [complains of] nausea this am, did not eat.No fever.Blood [culture/sensitivity], swab [culture/sensitivity] no growth.Will [discharge].¿ records for the blood/swab culture and sensitivity were not provided.Medical records dated (b)(6) 2014 state: ¿type: av graft ¿ unknown.Site: above elbow-left.Status: active.¿ ¿vascular access: vascular access reviewed.Current access is permanent and functioning well.¿ ¿patient is doing well and has no complaints.¿ records dated (b)(6) 2014 state the patient presented to the emergency room with complaints of cardiac arrest.¿preceding the arrest, the patient collapsed.The arrest occurred at home.¿ ¿unable to obtain hpi due to patient distress.[patient] ems husband states that [patient] walked into the bathroom and collapsed in the shower.She has a [history] of diabetes and is a dialysis [patient].She had low blood sugar upon ems arrival on scene ems states that there was blood coming out of her fistula.[patient] was supposed to have dialysis today.¿ the records indicate efforts were made to resuscitate the patient; however, the patient expired approximately 30 minutes after arrival at the hospital.A coroner¿s summary of investigation report dated (b)(6) 2014 states: ¿possible accidental death via fistula burst in left arm.Dialysis patient.¿ ¿circumstances of death¿they [sic] decedent had been having dialysis treatments 3 times a week for the last 3 to 3 ½ years.The decedent¿s daughter¿stated that the decedent was fine last night, (b)(6) 2014.¿ ¿the decedent had taken her insulin as usual and did not have any health complaints.¿ ¿the decedent normally wakes up on dialysis treatment days at approximately 0300 hours.¿ ¿the decedent suddenly then walked from her bedroom, past her sister, to the bathroom.Her sister said something to her, but the decedent did not respond to her.Within just a few moments, the decedent suddenly collapsed in the bathroom¿.She was not responding.¿ ¿the family noticed blood starting to pool around the decedent.¿ ¿as they repositioned the decedent, blood was spurting from her arm.Paramedics arrived quickly and they started cardiopulmonary resuscitation.They transported the decedent to (b)(6) hospital, emergency room (er), arriving at approximately 0455 hours.All life saving measures were attempted till the decedent was pronounced at 0527 hours by dr.(b)(6).¿ the (b)(6) 2014 coroner¿s summary of investigation report states: ¿medical history: ¿the decedent was an insulin dependent diabetic and was on dialysis.She had broken her foot by twisting it wrong approximately 6 years ago.The decedent had off and on swelling with infection since then.The decedent was scheduled to see her foot doctor later today, (b)(6) 2014.She had stent placement approximately 5-6 years ago.They [sic] decedent did not have any other known health problems.¿ ¿per the decedent¿s daughter, the decedent took blood pressure medication, insulin twice a day, and another unknown medication.¿ the (b)(6) 2014 coroner¿s summary of investigation report further states: ¿the decedent¿s sister¿found a tissue in the bedroom with apparent blood on it.She did not know if the decedent may have started bleeding in the bedroom and then went into the bathroom.Per family, the decedent did not have any history of having any difficulty with her dialysis or bleeding.¿ per the coroner, ¿the decedent had a large amount of apparent dried blood noted to her arms and legs.There was a black tourniquet tightly around the decedent¿s upper left arm.An open wound was noted to the decedent¿s left upper arm, above the elbow.¿ an autopsy report dated (b)(6) 2014 notes the following pathologic findings: ¿i.Failure of hemodialysis shunt, left upper arm.Ii.History of dialysis-dependent renal failure.Iii.Cardiomegaly (590 grams) with severe multi-vessel coronary artery atherosclerosis.Iv.Morbid obesity.¿ ¿cause of death: it is my opinion that this (b)(6)¿.Died as a result of failure of hemodialysis shunt.Manner of death: accident.¿ it is unclear at this time whether the coroner is referring to the gore propaten® vascular graft implanted on (b)(6) 2010 or the unknown graft (no product id provided) implanted on (b)(6) 2011.Additionally, it is unclear which graft the coroner is referring to as ¿failing¿ and leading to the death.The (b)(6) 2014 autopsy report states: ¿evidence of injury: on the anterior left mid biceps region is a circular 2 mm defect in the skin with a surrounding rim of hyperemia which is up to 5 mm in maximum dimension.There is some adherent blood on the marginating skin.Dissection of the underlying soft tissue reveals a dialysis shunt immediately beneath the skin defect.The shunt itself contains a 2 mm perforating defect.¿ it is unclear at this time whether the coroner is referring to the gore propaten® vascular graft implanted on (b)(6) 2010 or the unknown graft (no product id provided) implanted on (b)(6) 2011.The gore® propaten® vascular graft instructions for use provides the following: "complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/ or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.".
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Manufacturer Narrative
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Added additional information from provided medical records.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2010 state: ¿this (b)(6)-year-old female has been started on dialysis this week at (b)(6) hospital.I have been asked to provide a vascular surgery consultation for permanent dialysis access.¿ physical exam notes state: ¿she has an indwelling right chest permacath catheter.The patient· is right arm dominant.Evaluation of the left arm shows adequate filling of the radial and ulnar arteries in the palmar arch.¿ assessment and plan notes state: ¿end-stage renal disease needing long-term dialysis access.I discussed with the patient at length fistula versus graft, possible complications including but not limited to death, bleeding, re-operation, infection, steel syndrome, injury to associated organs or structures either temporary or permanent, possible need for prolonged hospitalization for rehabilitation.¿ operative records dated (b)(6) 2011 state the patient underwent ¿thrombectomy of graft¿.Procedures performed state: ¿access to graft/fistula¿; ¿angiogram of av graft/fistula¿; ¿arteriogram¿; ¿thrombectomy¿; venous angioplasty, transluminal balloon¿; ¿rhythm ecg with interpretation¿.Diagnoses state: ¿clotted dialysis device¿; ¿stricture/compression of vein¿.The records state: ¿interpretation of angiogram: access: the angiogram revealed that the patient has a brachial-basilic loop graft in the left forearm.The arterial side is medial.There is an 80% stenosis at the venous anastomosis.Draining veins: the drainage of the graft is via the basilic vein (via two venous channels) which is normal in appearance.Central veins: the central veins appear normal.¿ the (b)(6) 2011 records continue: ¿thrombectomy: an over-the-wire python catheter was inserted through the sheath and passed across the arterial anastomosis.Using this catheter, the entire graft was cleared of thrombus¿clot fragments were aspirated through the sheath.Fragments of thrombus were removed and discarded.Due to residual thrombus in the venous limb or the graft, a trerotola device was used to macerate the remaining clot.Following this procedure the patient had a strong pulse up to the level of the second cannulation site.Venous angioplasty: the lesion present at the venous anastomosis was dilated using a 6 x 4 angioplasty balloon.Pressure was applied by hand using a syringe assembly.The lesion dilated with 0% residual.The entire venous side of the graft was dilated using this angioplasty balloon.Radiocontrast was injected through the sheath to check for flow and for evidence of complication.¿ the (b)(6) 2011 operative report state: ¿interpretation of arteriogram: brachial artery: there is excellent flow within the brachial artery.No evidence of stenosis was seen.Arterial anastomosis: the arterial anastomosis appeared to be normal.Juxta-anastomotic graft: no abnormalities were seen in this area.¿ ¿at the end of the procedure, good flow was present within the graft and its draining veins.The identified areas of stenosis were improved.¿ the gore® propaten® vascular graft instructions for use provides the following: "complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/ or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.".
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Manufacturer Narrative
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It was reported a gore® propaten® vascular graft was implanted as an arteriovenous access graft for dialysis treatments.The following is a summary of the information, regarding this event, provided to w.L.Gore & associates: (b)(6) 2010 patient was implanted with a left forearm brachial artery cephalic vein, 4 mm to 7 mm tapered arteriovenous graft to treat end stage renal disease.Surgeon (b)(6) md.(b)(6) 2011 examination of the arteriovenous graft (avg) had no evidence of thrill or bruit and physician (name not provided) recommended thrombectomy and possible revision.(b)(6), 2011 thrombectomy (procedure details not provided) of avg.(b)(6) 2011 examination of avg exhibited thrill & bruit absent.(b)(6) 2011 patient underwent revision of left forearm arteriovenous graft without thrombectomy- which was reportedly unsuccessful and the avg was ligated.(b)(6) 2011 patient underwent a procedure (details not provided) for creation of av fistula nonautogenous graft- in the left upper arm.[presumed implantation of the reported propaten® graft].Following implantation, the patient reportedly received dialysis treatments 3x/week (start date not provided).It was reported to gore that a patient alleges to have been implanted with a gore device that ¿was used in a normal and foreseeable manner by plaintiff for the purpose of regular dialysis treatment.¿ it was reported the patient was found unconscious and bleeding from her left upper arm while in her home.Despite emergency treatment, the patient expired (b)(6) 2014.(b)(6) 2014 autopsy report concluded the following: pathologic findings: i.Failure of hemodialysis shunt, left upper arm.Ii.History of dialysis-dependent renal failure.Iii.Cardiomegaly (590 grams) with severe multi-vessel coronary artery atherosclerosis.Iv.Morbid obesity.Cause of death: ¿it is my opinion that this 59-year-old black female, [name redacted], died as a result of failure of a hemodialysis shunt.¿ manner of death: accident.The specimen was initially examined grossly at the (b)(6) coroner¿s office (b)(6) on (b)(6) 2019.The specimen was subsequently returned to w.L.Gore & associates for investigation.Submitted in formalin was reportedly a gore® propaten® vascular graft fragment with overlying tissue.The specimen had been transected and longitudinally opened prior to arrival at w.L.Gore & associates.The graft was firmly adhered to the overlying skin.A focal circular ulcer (hole) was present in the epidermis/dermis/subcutaneous tissue that directly communicated with the lumen of the graft.Affected skin surrounding the ulcer was discolored light tan and dark red-brown.The luminal surface of the graft fragment was covered in light tan tissue intermixed with locally extensive areas that were dark red-brown including an area adjacent to the hole.Histopathological examination of a representative cross-section through the ulcer was performed.There was no evidence of infection in the vascular graft or overlying skin/ulcer.The collective of gross and microscopic observations indicated that the ulcer and healing response to the myriad of cannulation sites was chronic.The presence of hemorrhage and acute thrombus along the ulcer¿s edges suggested that a recent bleeding incident had occurred.The graft fragment was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the graft was examined for material disruptions with the aid of a stereomicroscope.Disruptions identified were not associated with handling or manufacturing process at w.L.Gore & associates.The disruptions were consistent with severe cannulation disruptions, resulting in holes in the graft material, in conjunction with suboptimal cannulation technique.The transections were consistent with excise at autopsy.Section c1.Name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 3281153pp010.The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].
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Manufacturer Narrative
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H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g07002: appropriate term not available for false claim.No further investigation is required at this time.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as false claim and no problem detected.Brief chronology: (b)(6) 2010: ¿she has insulin-dependent diabetes for more than 10 years, has not been really controlled.¿ hemoglobin a1c levels: ¿out of control.¿ range 10.5 ¿ 11 [<5.7].(b)(6) 2010: ¿stage iv kidney disease secondary to diabetic nephropathy.¿ renal failure requiring long-term dialysis with access.Temporary dialysis catheter placement.(b)(6) 2010: insertion left forearm brachial artery cephalic vein 4 to 7 mm taper av [arteriovenous] graft.[implant: gore® propaten® vascular graft, (b)(6)/3281153pp010, 4-7mm x 45cm].(b)(6) 2011: thrombectomy of av fistula of the left forearm av graft.(b)(6) 2011: access to graft/fistula.Angiogram of av graft/fistula.Arteriogram.Thrombectomy.Venous angioplasty, transluminal balloon.(b)(6) 2011: revision of left forearm arteriovenous graft without thrombectomy.Explore brachial artery.(b)(6) 2011: insertion left upper arm av graft 4 to 7 mm taper.[implant: gore® propaten® vascular graft].[product id not provided].(b)(6) 2011 ¿ (b)(6) 2014: left upper arm graft consistently accessed three times per week for dialysis.(b)(6) 2014: redness noted to area surrounding access site.Patient stated: ¿may have scratched area.¿ (b)(6) 2014: redness over av fistula with drainage.Blood cultures obtained.Initiated on iv vancomycin every 6 hours for possible access infection.(b)(6) 2014: vascular access reviewed.Graft with positive thrill/bruit.(b)(6) 2014: arrived to emergency department in cardiopulmonary arrest.Per ems: ¿patient was in the bathroom getting ready to take a shower and her left upper extremity fistula burst and patient was actively spurting blood upon arrival and patient was unresponsive.Tourniquet placed to control bleeding and acls [advanced cardiovascular life support] and cpr [cardio pulmonary resuscitation] initiated.¿ expired at 5:27 am.(b)(6) 2014: autopsy: final pathologic findings: i.Failure of hemodialysis shunt, left upper arm.Ii.History of dialysis-dependent renal failure.Iii.Cardiomegaly (590 grams) with severe multi-vessel coronary artery atherosclerosis.Iv.Morbid obesity.¿ cause of death: ¿it is my opinion that this 59-year-old black female, gloria jackson, died as a result of failure of a hemodialysis shunt.¿ ¿ evidence of injury: ¿on the anterior left mid biceps region is a circular 2 mm defect in the skin with a surrounding rim of hyperemia which is up to 5 mm in maximum dimension.There is some adherent blood on the marginating skin.Dissection of the underlying soft tissue reveals a dialysis shunt immediately beneath the skin defect.The shunt itself contains a 2 mm perforating defect.¿ based upon the information received, the device remained in the patient and was not available for evaluation.Review of the manufacturing records verified that the lot met all pre-release specifications.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 3281153pp010.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions: d17: appropriate code/term not available for ¿false claim¿.H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g07002: appropriate term not available for false claim.No further investigation is required at this time.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as false claim and no problem detected.Brief chronology: (b)(6)2010: ¿she has insulin-dependent diabetes for more than 10 years, has not been really controlled.¿ hemoglobin a1c levels: ¿out of control.¿ range 10.5 ¿ 11 [<5.7].(b)(6)2010: ¿stage iv kidney disease secondary to diabetic nephropathy.¿ renal failure requiring long-term dialysis with access.Temporary dialysis catheter placement.(b)(6)2010: insertion left forearm brachial artery cephalic vein 4 to 7 mm taper av [arteriovenous] graft.[implant: gore® propaten® vascular graft, h470045a/3281153pp010, 4-7mm x 45cm].(b)(6)2011: thrombectomy of av fistula of the left forearm av graft.(b)(6)2011: access to graft/fistula.Angiogram of av graft/fistula.Arteriogram.Thrombectomy.Venous angioplasty, transluminal balloon.(b)(6)2011: revision of left forearm arteriovenous graft without thrombectomy.Explore brachial artery.(b)(6)2011: insertion left upper arm av graft 4 to 7 mm taper.[implant: gore® propaten® vascular graft].[product id not provided].(b)(6)11 ¿ (b)(6)2014: left upper arm graft consistently accessed three times per week for dialysis.(b)(6)2014: redness noted to area surrounding access site.Patient stated: ¿may have scratched area.¿ (b)(6)2014: redness over av fistula with drainage.Blood cultures obtained.Initiated on iv vancomycin every 6 hours for possible access infection.(b)(6)2014: vascular access reviewed.Graft with positive thrill/bruit.6/3/14: arrived to emergency department in cardiopulmonary arrest.Per ems: ¿patient was in the bathroom getting ready to take a shower and her left upper extremity fistula burst and patient was actively spurting blood upon arrival and patient was unresponsive.Tourniquet placed to control bleeding and acls [advanced cardiovascular life support] and cpr [cardio pulmonary resuscitation] initiated.¿ expired at 5:27 am.(b)(6)2014: autopsy: final pathologic findings: i.Failure of hemodialysis shunt, left upper arm.Ii.History of dialysis-dependent renal failure.Iii.Cardiomegaly (590 grams) with severe multi-vessel coronary artery atherosclerosis.Iv.Morbid obesity.Cause of death: ¿it is my opinion that this 59-year-old black female, (b)(6), died as a result of failure of a hemodialysis shunt.¿ evidence of injury: ¿on the anterior left mid biceps region is a circular 2 mm defect in the skin with a surrounding rim of hyperemia which is up to 5 mm in maximum dimension.There is some adherent blood on the marginating skin.Dissection of the underlying soft tissue reveals a dialysis shunt immediately beneath the skin defect.The shunt itself contains a 2 mm perforating defect.¿ based upon the information received, the device remained in the patient and was not available for evaluation.Review of the manufacturing records verified that the lot met all pre-release specifications.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 3281153pp010 additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Search Alerts/Recalls
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