MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Exsanguination (1841); Hemorrhage/Bleeding (1888)

Event Date 06/03/2014

Event Type  Death  

Event Description

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.¿ 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.

Manufacturer Narrative

Initial reporter's complete address :(b)(6).(b)(4).Lot number: unknown.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)].

Manufacturer Narrative

H6: updated investigation finding: c23: usage problem identified; c91874: cause traced to user.H6: health effect impact code: f02: the cessation of life.H6: medical device component: g04134: tube.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Brief chronology: on (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].On (b)(6) 2010: ¿stage iv kidney disease secondary to diabetic nephropathy.¿ renal failure requiring long-term dialysis with access.Temporary dialysis catheter placement.On (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].On (b)(6) 2011: thrombectomy of av fistula of the left forearm av graft.On (b)(6) 2011: access to graft/fistula.Angiogram of av graft/fistula.Arteriogram.Thrombectomy.Venous angioplasty, transluminal balloon.On (b)(6) 2011: revision of left forearm arteriovenous graft without thrombectomy.Explore brachial artery.On (b)(6) 2011: insertion left upper arm av graft 4 to 7 mm taper.[implant: gore® propaten® vascular graft].[product id not provided].On (b)(6) 2011 ¿ (b)(6) 2014: left upper arm graft consistently accessed three times per week for dialysis.On (b)(6) 2014: redness noted to area surrounding access site.Patient stated: ¿may have scratched area.¿ on (b)(6) 2014: redness over av fistula with drainage.Blood cultures obtained.Initiated on iv vancomycin every 6 hours for possible access infection.On (b)(6) 2014: vascular access reviewed.Graft with positive thrill/bruit.On (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.On (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.¿ the device was able to be returned to gore for evaluation and a direct product analysis was conducted.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed through an explant evaluation.Although product identification and lot information were not provided, standard manufacturing procedures require lot history review before release of the device to ensure compliance with device specifications.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.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: unknown.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.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: rena gros ; 1500 n. 4th street; 9285263030
• MDR Report Key: 14083979
• MDR Text Key: 289069975
• Report Number: 2017233-2022-00001
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 129 KG