MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number RRT07070080L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Analysis report from third party was received and will be further investigated.A review of the manufacturing records indicated the lot met all pre-release specifications.

Event Description

It was reported to gore that patient underwent endovascular treatment for an acute ischemia of the left lower limb with a gore-tex® vascular graft - thin-walled removable ringed due to a severe radiation-induced stenosis of the visceral aorta.It was stated that the prosthesis was implanted on (b)(6) 2020 as an axillo-left-femoral bypass.It was reported that on (b)(6) , 2021, after about 2 months, the prosthesis was explanted because an in-situ reconstruction was performed.The surgeon noted that the axillo-femoral bypass was thrombosed, and a seroma was noticed.

Manufacturer Narrative

Explant scientist observations: ¿ segment 1: the abluminal surface was covered in brown/tan and yellow (presumptive adipose) tissue.Dark red/brown tissue was observable in the lumen, when looking at extremity b.The luminal patency could not be determined, with the information provided.Both extremities were transected.Extremity b, was ovular and presented in a partially flattened manner.The segment measured approximately 70 mm (length) x 6 mm (extremity a) x 3-10 mm (extremity b) and presented in a ushape.¿ segment 2: the abluminal surface was generally devoid of tissue, except for scattered foci of tan and red/brown tissue.The lumen was occluded by dark red/brown tissue.Both extremities were transected.An area of disrupted rings with associated graft material flattening was present in the midregion of the graft.The segment measured approximately 290 mm (length) x 7 mm (extremity diameter) and presented in a ¿bunched/multi-turned¿ manner.¿ segment 3: the abluminal surface was generally devoid of tissue, except for scant brown tissue being present in areas.The lumen was patent and contained dark red/brown tissue on the luminal surface.Two disrupted rings were present near extremity a.And the remainder of the rings were not present.Both extremities were transected.Extremity a, was irregularly transected and partially invaginated.Extremity b, was beveled with blue, monofilament suture/suture fragments being present.Cannulation needle holes and two partial transections were present around the edge of extremity b.The segment measured approximately 30 mm (length).From gross images all material disruptions (i.E., material transections/cuts, flattening, disrupted/missing rings, suture needling holes), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors) and suturing.Likely used, during surgical procedure(s).Request for additional analysis? no.Reason: based on the explant scientist¿s review of the geprovas report and reason for removal (planned reconstruction), no additional analysis is requested.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11543123
• MDR Text Key: 249112532
• Report Number: 2017233-2021-01788
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611034
• UDI-Public: (01)00733132611034(17)250830
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RRT07070080L
• Device Catalogue Number: RRT07070080L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male