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

Device Problem Crack (1135)

Patient Problems Unspecified Infection (1930); Pseudoaneurysm (2605)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2018 was taken as the date of event, because the infection was diagnosed on this date.On (b)(6) 2018 was taken as the best estimate of the date of implant.The phone number of the physician could not be obtained.The investigation involved e-mail communication with the healthcare professional performing the explant evaluation.The explanted device was not returned to gore for evaluation.At present the device is located at an independed laboratory (b)(6).The independed laboratory geprovas provided gore with a preliminary explant evaluation.No analysis of relevant production records in view of supporting the identification of possible causes for the adverse event could be performed, because the lot number of the device remains unknown.

Event Description

A gore-tex® vascular graft was implanted in a (b)(6) female patient in (b)(6) 2018 as a femoro-femoral bypass in order to treat a critical ischemia.Reportedly the patient did not have a history of pre-existing infection in the field of treatment.It was reported, that, on (b)(6) 2018, an infection was identified.It was stated, that on (b)(6) 2018, imaging was performed presenting an anastomotic pseudoaneurysm and a possible breach near the anastomosis.Reportedly, on (b)(6) 2018, the gore-tex® vascular graft was explanted due to the infection and the pseudoaneurysm.It was reported, that the surgeon performed a prostheto-prosthetic bypass to repair the issue locally.It was stated, that the patient received antipyretic and antibiotic treatment.It was reported, that the patient is doing well.In the provided explant report it is stated, that the gore-tex® vascular graft was separated in two segments.One of this explanted segments revealed a total obstruction of the prosthetic lumen due to the loss of some reinforcement rings allowing the graft to collapse.Moreover, a green multifilament has been used as a ligature.The physician stated, that the infection was neither caused by the gore-tex® vascular graft nor did the gore-tex® vascular graft contribute to the infection.The physician also stated, that the infection was neither caused by the procedure to implant the gore-tex® vascular graft nor did the procedure contribute to the infection.

Event Description

A gore-tex® vascular graft was implanted in a 52-year-old female patient on (b)(6) 2018 as a femoro-femoral bypass in order to treat a critical ischemia.Reportedly the patient did not have a history of pre-existing infection in the field of treatment.It was reported, that, on (b)(6) 2018, an infection was identified.It was stated, that on (b)(6) 2018, imaging was performed presenting an anastomotic pseudoaneurysm and a possible breach near the anastomosis.Reportedly, on (b)(6) 2018, the gore-tex® vascular graft was explanted due to the infection and the pseudoaneurysm.It was reported, that the surgeon performed a prostheto-prosthetic bypass to repair the issue locally.It was stated, that the patient received antipyretic and antibiotic treatment.It was reported, that the patient is doing well.The physician stated, that the infection was neither caused by the gore-tex® vascular graft nor did the gore-tex® vascular graft contribute to the infection.The physician also stated, that the infection was neither caused by the procedure to implant the gore-tex® vascular graft nor did the procedure contribute to the infection.

Manufacturer Narrative

B5: updated event description.

Event Description

A gore-tex® vascular graft was implanted in a 52-year-old female patient in (b)(6) 2018 as a femoro-femoral bypass in order to treat a critical ischemia.Reportedly the patient did not have a history of pre-existing infection in the field of treatment.It was reported, that, on (b)(6) 2018, an infection was identified.It was stated, that on (b)(6) 2018, imaging was performed presenting an anastomotic pseudoaneurysm and a possible breach near the anastomosis.Reportedly, on (b)(6) 2018, the gore-tex® vascular graft was explanted due to the infection and the pseudoaneurysm.It was reported, that the surgeon performed a prostheto-prosthetic bypass to repair the issue locally.It was stated, that the patient received antipyretic and antibiotic treatment.It was reported, that the patient is doing well.In the provided explant report it is stated, that the gore-tex® vascular graft was separated in two segments.One of this explanted segments revealed a total obstruction of the prosthetic lumen due to the loss of some reinforcement rings allowing the graft to collapse.Moreover, a green multifilament has been used as a ligature.The physician stated, that the infection was neither caused by the gore-tex® vascular graft nor did the gore-tex® vascular graft contribute to the infection.The physician also stated, that the infection was neither caused by the procedure to implant the gore-tex® vascular graft nor did the procedure contribute to the infection.

Manufacturer Narrative

B5: updated event description: h6-code 4112: the physician shared one image of the explanted device with gore.H6-code 213: the imaging evaluation states the following: as the images received were not in dicom format, a full imaging evaluation could not be completed.Gore cannot make any conclusions or guarantees that non-dicom images are complete, accurate and lack alteration.Thus, findings noted are within the best ability of the reviewers but the extent and accuracy of the findings may be limited due to the completeness, format and/or quality of the images provided.Gore cannot guarantee that it has been able to capture all key findings or that the findings are accurate.Summary: one jpeg image received for evaluation.No name, date, time or demographics included on image.Cannot window/level or manipulate image in any way.There appears to be a fem/fem bypass present.There appears to be a possible pseudo aneurysm present in the region of the distal right external iliac artery, with imaging provided.

Manufacturer Narrative

H6-code 4114: the explanted device was not returned to gore.The physician sent it to a third party (geprovas) for investigation.They shared their analysis reports with gore.Gore reviewed and evaluated these reports.H6-code 213: the explant evaluation states the following: level 1 analysis: tissue present: yes.Segment 1: red to dark red tissue was present on the luminal surface.The lumen was reported to be ¿broadly clear¿ but this could not be verified with the information provided.The abluminal surface was generally devoid of tissue, except for a small foci of yellow tissue near extremity a.Both ends were transected with extremity b presenting in an ovular fashion.Only two rings were visible on the fragment, near extremity a.Circumferential serration marks were present on the abluminal surface, near extremity b.Segment 2: lumen patency could not be determined with the information provided.The albumen was generally devoid of tissue, except for a large foci of yellow and tan tissue near extremity b.Minimal tan to dark brown tissue was present at extremity a.The fragment retained a c-shape with approximately half the device having rings present (extending towards extremity a) and the other half being devoid of rings.The region that was devoid of rings was flattened to partially-flattened.In the intrados regions of the c-shape, the graft material was pinched in two areas.It could not be determined if c-shape and pinched areas originated while in-vivo or post-explant (device storage in bottle).One ring on the fragment appeared to be disrupted but still attached.Extremity b was transected and presented ovular in shape.Blue running suture and a blue multifilament were present at extremity a, suggesting a site of anastomosis.Request for additional analysis: yes.Reason: to better understand the material appearance at the extremities in the level 1 report, a level 2 post-digestion analysis was requested and performed by geprovas.Level 2 analysis: segment 1: a piece of the material was cut from extremity a on the fragment (presumptive histopathologic sampling).Segment 2: the area devoid of rings had multiple serration marks present with radial film disruption.The transections made at extremity a were ¿unregularly¿ beveled.Holes were present along the transected edge of extremity a, consistent with those caused by running suture.A piece of the material was cut from extremity b on the fragment (presumptive histopathologic sampling).From gross and post-digestion images, all material disruptions (i.E., material transections/cuts, serration marks, and missing rings), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors), grasping/ pulling with surgical instrumentation (i.E., hemostat or forceps), or planned ring removal, likely caused during a surgical procedure.No conclusions about the infection of the graft fragments and cause of the pseudoaneurysm could be drawn from this analysis.

• Brand Name: GORE-TEX VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9604734
• MDR Text Key: 186738033
• Report Number: 2017233-2020-00046
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 73