MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problems Material Split, Cut or Torn (4008); Device Stenosis (4066)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Ischemia (1942); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 09/10/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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.

Event Description

The following article was reviewed: non-anastomotic complete eptfe axillobifemoral bypass disruption and thrombosis following shoulder dislocation benoît lucereau, arielle bellissard, frédéric beck, delphine dion, frédéric heim, nabil chakfe, anne lejay ejves short reports volume 44, 2019, pages 15-18 issn 2405-6553 https://doi.Org/10.1016/j.Ejvssr.2019.06.004 available online 30 july 2019.This is a report of a case of a 70-year-old man presenting with left shoulder dislocation with a hematoma about august 29, 2012.The dislocation was reduced immediately.About september 10, 2012, the patient presented with rutherford 2b bilateral lower limb ischemia related to thrombosis of a bifurcated gore-tex® stretch vascular graft (8 mm, standard wall) axillo-bifemoral bypass that was implanted on january 26, 2007, for treatment of an aorto-enteric fistula secondary to an infected aorto-bifemoral bypass implanted previously (not further specified).On doppler ultrasound, there was a clear suppression of the continuity between upstream and downstream of the graft.Therefore, on september 25, 2012, the patient underwent surgery for graft thrombectomy.During the surgery a pulsatile hematoma was noted at the upper part of the hemithorax.A non-anastomotic pseudoaneurysm associated with non-anastomotic complete transverse disruption of the gore graft was found in the middle of the graft outside a suture zone.The date of the disruption remains unknown.To resolve the rupture they removed the segment of the gore graft containing the lesion and a small interposition graft between the non-disrupted portions of the axillobifemoral bypass was performed.The patient recovered uneventfully.The retrieved specimen was sent to geprovas (european research group on grafts used in vascular surgery) as part of a european retrieval explant program and was submitted to a standardized protocol for evaluation.Analysis of the explant showed that the rupture occurred at the level of a ringed external support.Ongoing tears also occurred on the posterior wall of the graft at the level of this external support.Microscopic examination demonstrated partial rupture at the level of the external support and partial wrapping detachment at the edge of the transverse rupture.Based on these findings the author assumes that the external ring caused repeated microtrauma, exacerbated by the distension of the graft during the systole and the movement of the rib cage, resulting in weakening and finally rupture of the graft.

Manufacturer Narrative

Cause investigation and conclusion: a unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.The physician has sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted vascular graft after cleaning) was performed by the third party.They provided analysis results to gore, which were reviewed by gore explant scientists.The explant evaluation summary states the following: two vascular graft fragments were included within a pink/tan tissue capsule (presumptive seroma) that had been transected.One side of the capsule (presumptive superficial/external) was pink/tan and yellow (presumptive adipose) tissue with black/brown marks (presumptive electrocautery).The device fragment edges on the superficial side were ovular, which is consistent with cutting via sharp surgical instrumentation (i.E., scalpel/scissors).The other side of the capsule (presumptive deep/internal) was pink/tan and tan/yellow (presumptive fibrous) tissue.The tissue on the deep/ruptured side had grown to cover the ruptured vascular graft surfaces.The publication showed the post-digestion graft fragments aligning at the ruptured ends.The growth of the tissue over the areas of rupture, presence of fibrous tissue, and lack of coagulated blood suggest that the rupture may have occurred at a time earlier than the patient¿s shoulder dislocation event.However, the exact time and cause of the disruption cannot be determined with the information provided.No discrepancies were noted between the published outcomes within the reviewed literature and report provided by the 3rd party.Based on the literature, the report provided by the 3rd party, and the subsequent investigation we are unable to determine the cause of this incident and assign a root cause.

Manufacturer Narrative

H6-codes b15 and c19: the explanted device is in possession of a third party (gepromed), and it was not forwarded to gore for evaluation.Instead the third party provided their explant evaluation report to gore for evaluation.The gore explant scientist summary states the following.Two vascular graft fragments were included within a pink/tan tissue capsule (presumptive seroma) that had been transected.One side of the capsule (presumptive superficial/external) was pink/tan and yellow (presumptive adipose) tissue with black/brown marks (presumptive electrocautery).The device fragment edges on the superficial side were ovular, which is consistent with cutting via sharp surgical instrumentation (i.E., scalpel/scissors).The other side of the capsule (presumptive deep/internal) was pink/tan and tan/yellow (presumptive fibrous) tissue.The tissue on the deep/ruptured side had grown to cover the ruptured vascular graft surfaces.The publication showed the post-digestion graft fragments aligning at the ruptured ends.The growth of the tissue over the areas of rupture, presence of fibrous tissue, and lack of coagulated blood suggest that the rupture may have occurred at a time earlier than the patient¿s shoulder dislocation event.However, the exact time and cause of the disruption cannot be determined with the information provided.No discrepancies were noted between the outcomes published within the present reviewed literature and the explant evaluation report provided by gepromed.

Manufacturer Narrative

Section b1 the present event represents a malfunction that has led to a serious injury.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15391467
• MDR Text Key: 299571858
• Report Number: 2017233-2022-03301
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K901641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male