| Device Problems
Contamination (1120); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
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| Event Date 07/11/2017 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2009, whereby an alleged gore device was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: small bowel obstruction ((b)(6) 2013), mesh removal, pain, adhesions, additional surgeries.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Added medical history.Added brand name.Code 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: correct date of implant for event description is on (b)(6) 2009.Records prior to 7/26/2007 were not provided.Operative records dated on (b)(6) 2007 indicate the patient underwent exploratory laparotomy with ventral lysis, reduction of internal hernia, closure of mesenteric defect, central line placement.The records state preoperative/postoperative diagnosis ¿small bowel obstruction.¿ operative records dated on (b)(6) 2007 state: ¿[the patient] is a 67-year-old gentleman with small bowel obstruction refractory to conservative management he comes to the operating room today for exploration.¿ the records state: ¿findings: there was a mesenteric defect at the ileocolic anastomosis.This was reduced causing a small bowel obstruction.This was reduced, and the defect was repaired.There were several significant additional adhesions, which were lysed.¿ operative records dated on (b)(6) 2007 continue: ¿a midline incision was made with a #10 blade scalpel.Dissection was carried down through the subcutaneous tissue, fascia, and peritoneum with electrocautery.The small bowel was delivered through the abdomen.There were several adhesions to the ventral abdominal wall to the liver, to the mesentery, and to the small bowel itself.These were lysed with sharp dissection.¿ operative records dated on (b)(6) 2007 state: ¿there was an internal hernia at the patient's previous ileocolic anastomosis.This was reduced.All of the small bowel was viable.The mesenteric defect was closed with a running #3-0 vicryl suture.The small bowel contents were milked retrograde into the stomach, which were then suctioned out with a nasogastric tube.There was good hemostasis, so the small bowel was returned to the abdomen.The fascia was closed with a running looped 0 pds suture.The wound was irrigated and closed with surgical staples.Sterile dressings were applied.¿ operative records dated on (b)(6) 2008 indicate the patient underwent ileocolic resection with primary anastomosis and enterolysis.Preoperative/postoperative diagnosis ¿recurrent colon cancer.¿ the records state: ¿[the patient] is a 68-year-old gentleman with recurrent colon cancer at his ileocolic anastomosis, so he comes to the operating room today for exploration and resection.¿ operative records dated on (b)(6) 2008 state: ¿findings: there were significant adhesions, requiring extensive enterolysis.There was a recurrent mass at the ileocolic anastomosis, so margins approximately distal to this were resected, and reanastomosis was performed with the ileum to the sigmoid colon in primary fashion.There was no other palpable intraperitoneal adenopathy or liver nodularity.¿ operative records dated on (b)(6) 2008 continue: ¿the patient's previous midline incision was incised with a 10-blade scalpel, and dissection was carried down through the subcutaneous tissues and fascia with electrocautery.The fascia was grasped and retracted, and sharp dissection was used to enter the peritoneal cavity.There were significant small bowel adhesions to the underside of the ventral abdominal wall.These were freed with sharp and blunt dissection.The abdomen then was very adherent with small bowel adhesions, so meticulous dissection with sharp, blunt and electrocautery dissection was used to free the small bowel.¿ operative records dated on (b)(6) 2008 state: ¿the small bowel was freed from the ligament of treitz, then to the ileocolic anastomosis.There was palpable mass at the anastomosis and some nodularity within the immediate underlying mesentery.There was no evidence of other palpable peritoneal adenopathy.The liver was soft and within normal limits.The small bowel approximately 10 centimeters proximal to this was mobilized from its mesentery and divided with a gia 75 stapler.The sigmoid colon approximately 10 centimeters distal to this was mobilized from its mesentery with electrocautery dissection and divided with a gia-75 stapler.¿ operative records dated on (b)(6) 2008 state: ¿the mesentery was then divided with the ligasure device, and the specimen was passed off the table.The ileum was approximated to the colon, and enterotomies were made with electrocautery, and an anastomosis was created with a gia-75 stapler.The enterotomy was closed with a ta-60 stapler, and the excess tissue was excised.The ta-60 staple line was oversewn with a running 3-0 vicryl suture.A 3-0 vicryl stay suture was placed to lessen tension on the apex of the anastomosis, as well.The mesenteric defect was closed with a running 3-0 vicryl suture.The abdomen was irrigated with saline, which was suctioned out.The fascia was then closed with a running looped 0-pds suture.The wound was irrigated and closed with surgical staples.Sterile dressings were applied.¿ operative records dated on (b)(6) 2009 indicate the patient underwent 1.Laparoscopic incisional hernia repair with enterolysis 2.Right shoulder lipoma excision with 4 cm wound closure.Preoperative/postoperative diagnosis ¿incisional hernia, right shoulder lipoma.¿ the records state ¿[the patient] ¿is a 69-eyar-old gentleman with symptomatic reducible incisional hernia and a tender right shoulder iipoma.He comes to the operating room today for surgical intervention.¿ operative records dated on (b)(6) 2009 state: ¿findings: there were extensive small bowel adhesions.Laparoscopic enterolysis was performed in addition to incisional hernia repair with a 25 x20 cm piece of gore-tex dual mesh.Excision of right shoulder lipoma.¿ operative records dated on (b)(6) 2009 state: ¿a right upper quadrant stab incision was made with an #11 blade scalpel.A veress needle was inserted into the peritoneal cavity.Its position in the peritoneal cavity was confirmed by the saline drip test.The peritoneum was insufflated to a pressure of 15 millimeters of mercury pressure with carbon dioxide and a 5 millimeter visiport was inserted under direct visualization.A right lower quadrant stab incision was made, and a 12 millimeter visiport was inserted under direct visualization.A left lower quadrant stab incision was made, and a 5 millimeter visiport was inserted under direct visualization.¿ operative records dated on (b)(6) 2009 state: ¿there were extensive small bowel adhesions to the ventral abdominal wall.These were taken down with sharp dissection.Several hernia defects were identified.The margins around the defects were marked extra-corporally with a spinal needle.A piece of gore-tex dual mesh was brought to the field and cut to the appropriate size.It measured approximately 25 cm in the vertical direction and 20 cm in the horizontal direction.Its comers were tagged with #3-0 pds sutures.This was rolled and placed within the peritoneal cavity.It was then unrolled.The pds sutures were grasped through stab incisions with the gore suture passer.¿ operative records dated on (b)(6) 2009 state: ¿these were tied extra-corporally.The mesh was tacked to the ventral abdominal wall circumferentially with a 5 millimeter tacking device.The fascial defect around the 12 millimeter port was closed with an 0 vicryi suture with the gore suture passer.There was good hemostasis, so the peritoneum was decompressed.The wounds were anesthetized with 0.25% marcaine with epinephrine and closed with #4-0 monocryl subcuticular stitches.Sterile dressings were applied.Product identification records for the gore® dualmesh® biomaterial mentioned in the 2/24/2009 operative report were not provided.Records between 2/24/2009 and 1/22/2013 were not provided.Medical records dated on (b)(6) 2013 state: ¿patient is a very pleasant 73-year-old male presenting to the emergency department with complaint of abdominal pain.Patient describes onset of pain starting at i am this morning it woke him up from sleep.Patient describes waxing and waning waves of discomfort that is sharp and cramping.Patient states that the worse the pain as a 10 out of 10.Current discomfort as an 8/10.Patient has noted increasing distention of the abdomen.¿ medical records dated on (b)(6) 2013 continue: ¿patient has prior history of colon cancer diagnosed in 2007 with resection that year followed by further resection related to recurrence in 2008.Patient also reports bowel obstruction with adhesion lysis in the past.Patient reports small soft stool this morning and reports that prior to that last bowel movement was the day before.No recent constipation or diarrhea.Patient has had mild nausea at home but no vomiting.¿ medical records dated on (b)(6) 2013 state: ¿patient denies any chest pain shortness of breath or breathing difficulty.Patient denies having any dysuria urgency or frequency.Patient tried taking some miralax this morning as he had noticed there's been some increased difficulty with stooling and that he has needed to strain more than usual.Patient thought that this was related to dietary indiscretions with increased ingestion of bread products.Patient has not tried taking any medications at home for his discomfort but given persistence of discomfort presented to the emergency department for evaluation.No other complaints or concerns at this time.¿ medical records dated on (b)(6) 2013 state: ¿flat and upright abdomen indication: abdominal pain, likely obstruction.Findings: multiple air-fluid levels within the small bowel.Dilated loops of bowel as well.No definite free air.Findings concerning for small bowel obstruction.Consider ct followup.¿ operative records dated on (b)(6) 2013 indicate the patient underwent exploratory laparotomy with enterolysis.Preoperative/postoperative diagnosis ¿small bowel obstruction.¿ the records state: ¿[the patient] is a 73-year-old gentleman with a small bowel obstruction refractory to conservative treatment, so he comes to the operating room today for surgical intervention.¿ operative records dated on (b)(6) 2013 state: ¿findings: there were multiple adhesions.A standard enterolysis was performed.¿ the records state: ¿the patient's old biopsy incision was opened up with a 10 blade scalpel, and dissection was carried out through the subcutaneous tissues with electrocautery.The fascia and old hernia mesh were opened with a curved mayo scissors.There were some adhesions to the underside of the mesh, which were taken down with sharp and electrocautery dissection.There was a prominent adhesion which probably marked the transition zone of the portion of the ileum creating a trapping band to the upper abdomen.¿ operative records dated on (b)(6) 2013 state: ¿this band crossed near the ileocolic anastomosis.This was taken down with sharp dissection.There were multiple adhesions then that were freed starting from the ileocolic anastomosis all the way to the ligament of treitz.The bowel contents were then milked retrograde into the stomach and suctioned out.The abdomen was irrigated with saline, which was suctioned out.There was good hemostasis so the fascia and old hernia mesh were closed with a #1 prolene suture.The wound was irrigated and closed with surgical staples.Sterile dressings were applied.¿ discharge summary dated on (b)(6) 2013 indicates the patient was admitted to the hospital on (b)(6) 2013 for small bowel obstruction.The records indicate the patient underwent exploratory laparotomy with enterolysis.The records state: ¿mr.(b)(6) is a 73-year-old gentleman who developed worsening abdominal pain with nausea but no vomiting, and also bloating.He was seen in the clinic and subsequently admitted for small bowel obstruction.¿ discharge summary dated on (b)(6) 2013 states: ¿the patient was admitted.Surgery was consulted.He was given an extended trial of conservative treatment but failed to progress and actually started to get worse.He was brought to the operating room on (b)(6) 2013 and underwent a exploratory laparotomy with extensive enterolysis.¿ discharge summary dated on (b)(6) 2013 states: ¿postoperatively he returned to the surgical floor.He remained on bowel rest with ng decompression.He had a fairly prolonged ileus and his diet was then advanced as tolerated once he started to resume some bowel function.However, he got sick again and ng tube was re-placed and tpn was started.He continued again to have prolonged ileus, which slowly resolved and once again once he regained bowel function his diet was advanced as tolerated.On the day of discharge he was tolerating a general diet, ambulating without assistance, passing flatus, and having bowel movements.Incision is clean and dry.¿ records between 2/15/2013 and 3/10/2017 were not provided.Medical records dated on (b)(6) 2017 state: ¿with chronic infected mesh in this wound area, the wound is never expected to heal without surgical intervention.Patient is not interested in surgery so we are managing palliatively with antimicrobial wound filler and wound manager pouch.¿ medical records dated on (b)(6) 2017 state: ¿with chronic infected mesh in this wound area, the wound is never expected to heal without surgical intervention.We did discuss the option of being seen at the (b)(6) clinic or at the (b)(6) with one of their general surgeons for patien [sic] gi specialists.There is technology available now that allows for some tissue replacement and reduce scarring which will possibly reduce adhesions as well as reduce further risk of bowel obstruction.I would like this patient to talk to one of these specialists regarding that option if he is interested.I am running this by his primary care provider first to see which facility she would prefer he visit.In the past he has not then interested in surgery so we are managing palliatively with antimicrobial wound filler and wound manager pouch.Medical records dated on (b)(6) 2017 indicate patient was seen for ¿chronic abdominal wound infection, sequela, infected hernioplasty mesh, subsequent encounter, vitamin b12 defiency, peripheral polyneuropathy, hypergranulation.The records state: an area of about 9.5 x 7.5cm that was pooled drainage underneath the wound manager causing irritation to the surrounding skin.¿ records for the alleged explant of the gore device on (b)(6) 2017 were not provided.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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: conclusion code remains unchanged.This claim was withdrawn on 4/10/20, and the alleged product complaint is no longer being pursued at this time.The investigation will be completed with the available information.Conclusion code remains unchanged until the investigation is complete.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 patient codes.H6: updated device codes.H6: additional device codes: 3190.H6: updated conclusion codes.H6: additional conclusion codes: 4316: appropriate term / code not available is being used for "withdrawn complaint¿.Previous patient codes (1695, 1994, 2422) were reported based on the original complaint and are no longer applicable per gore¿s investigation.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span july 26, 2007 through may 25, 2017 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Medical records from february 24, 2009 through january 22, 2013, and from february 15, 2013 through march 10, 2017 were not provided.Medical records for the alleged explant on (b)(6) 2017 were not provided.Patient information: medical history: colon cancer, hypertension, bilateral renal cancer, history of dvt [deep venous thrombosis], peptic ulcer disease [pud], gastroesophageal reflux disease [gerd], smoking, quit 2007.Prior surgical procedures: unknown date: kidney surgery.Unknown date: prostatectomy.On (b)(6) 2007: exploratory laparotomy with ventral lysis, reduction of internal hernia, closure of mesenteric defect for small bowel obstruction.On (b)(6) 2008: ileocolic resection with primary anastomosis and enterolysis for recurrent colon cancer.Implant preoperative complaints: on (b)(6) 2009: ¿with symptomatic reducible incisional hernia and a tender right shoulder lipoma.He comes to the operating room today for surgical intervention.¿ implant procedure: laparoscopic incisional hernia repair with enterolysis.Right shoulder lipoma excision with 4 cm wound closure.Implant: ¿gore-tex dual mesh¿, 25cm x 20cm, product identification records were not provided.Implant date: on (b)(6) 2009 [hospitalization dates unknown].Description of hernia being treated: ¿there were extensive small bowel adhesions to the ventral abdominal wall.These were taken down with sharp dissection.Several hernia defects were identified.The margins around the defects were marked extra-corporally with a spinal needle.¿ implant size and fixation: ¿a piece of gore-tex dual mesh was brought to the field and cut to the appropriate size.It measured approximately 25 cm in the vertical direction and 20 cm in the horizontal direction.Its corners were tagged with #3-0 pds sutures.This was rolled and placed within the peritoneal cavity.It was then unrolled.The pds sutures were grasped through stab incisions with the gore suture passer.These were tied extra-corporally.The mesh was tacked to the ventral abdominal wall circumferentially with a 5 millimeter tacking device.The fascial defect around the 12 millimeter port was closed with an 0 vicryi suture with the gore suture passer.There was good hemostasis, so the peritoneum was decompressed.¿ relevant medical information: on (b)(6) 2013: ed visit: abdominal pain.Abdominal x-ray: ¿findings concerning for small bowel obstruction.¿ hospital admission.On (b)(6) 2013: exploratory laparotomy with enterolysis.¿the fascia and old hernia mesh were opened with a curved mayo scissors.There were some adhesions to the underside of the mesh, which were taken down with sharp and electrocautery dissection.¿ ¿there was good hemostasis so the fascia and old hernia mesh were closed with a #1 prolene suture.¿ on (b)(6) 2013: discharge summary: ¿postoperatively he returned to the surgical floor.He remained on bowel rest with ng decompression.He had a fairly prolonged ileus."he got sick again and ng tube was re-placed and tpn was started.He continued again to have prolonged ileus, which slowly resolved and once again once he regained bowel function his diet was advanced as tolerated.¿ on (b)(6) 2017: ¿with chronic infected mesh in this wound area, the wound is never expected to heal without surgical intervention.Patient is not interested in surgery so we are managing palliatively with antimicrobial wound filler and wound manager pouch.¿ on (b)(6) 2017: ¿with chronic infected mesh in this wound area, the wound is never expected to heal without surgical intervention.We did discuss the option of being seen at the (b)(6) clinic or at (b)(6) with one of their general surgeons for patient [sic] gi specialists.¿ on (b)(6) 17: ¿seen for ¿chronic abdominal wound infection, sequela, infected hernioplasty mesh, subsequent encounter.An area of about 9.5 x 7.5cm that was pooled drainage underneath the wound manager causing irritation to the surrounding skin.¿ ¿we are planning mesh removal surgery on (b)(6) at (b)(6).¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® biomaterial instructions for use also states, ¿use only nonabsorbable sutures, such as gore-tex" suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the mesh.The use of absorbable sutures may lead to inadequate anchoring of gore dualmesh" biomaterial to the host tissue and necessitate reoperation.¿ the instructions for use further state: ¿staples or helical tacks (also known as helical coils) can be used as an alternative to sutures.Staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation.¿ the instructions for use further state: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and / or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and / or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and / or a general lack of available detail or specificity related to an adverse event and / or device.Based upon the information received, status of the device is unable to be confirmed and therefore not available for evaluation.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through other records provided.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.Although a review of manufacturing and sterilization records could not be performed, all pre-release specifications are confirmed prior to release as part of quality system processes.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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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