MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number PAH090502

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

The exact date of event was not provided.It was stated that one and a half year after the implantation the increase of the aneurysm was diagnosed.Therefore the date of event is a best estimate.The present event involves two viabahn® devices.For each device a medwatch report is sent.See mfr number 2017233-2019-00121.

Event Description

The patient presented with an aneurysm (diameter of 5.0 cm) of the right popliteal artery which was treated using two gore® viabahn® endoprostheses with propaten bioactive surface on (b)(6) 2017.Follow-up examination results were as follows: 3 month follow-up: 4.5 cm; 6 month follow-up: 3.8 cm; 9 month follow-up: 5.0 cm.On unknown date, one and a half year after the implantation, imaging showed that the aneurysm further increased to a diameter of 5.4 cm.On (b)(6) 2019, both viabahn® devices have been explanted.

Manufacturer Narrative

Pma/510k: combination product was changed to "yes.".

Manufacturer Narrative

Combination product was changed to "yes".

Manufacturer Narrative

Date of event: since the first aneurysm growth was seen nine month after the implantation the date of event was best re-estimated ((b)(6) 2018).Event: updated.Implant date/explant date: updated.Ct images dated (b)(6) 2018 where provided for investigation.They illustrate a patent popliteal artery with what appears to be adequate distal runoff.The maximum diameter was approximately 51mm x 57mm.

Event Description

The patient presented with an aneurysm (diameter of 5.0 cm) of the right popliteal artery which was treated with two gore® viabahn® endoprostheses with propaten bioactive surface on (b)(6) 2017.Follow-up examination results were reported to gore as follows: 3 month follow-up: 4.5 cm; 6 month follow-up: 3.8 cm; 9 month follow-up: 5.0 cm; one and a half year follow-up: 5.4 cm.On (b)(6) 2019, both viabahn® devices have been explanted in an open surgery and a femoral-popliteal bypass (level unknown) was established.Three days after the surgery the patient was discharged from the hospital.

Manufacturer Narrative

H6-codes 3251 and 3252.Previous result codes were 3251 and 3251.The second code was now updated with 3252.

Manufacturer Narrative

H6-code 4315: w.L.Gore and associates cannot confirm the source of the reported endoleak and whether or not the failures identified in the explant report attributed to the endoleak and subsequent reintervention.

Manufacturer Narrative

H6-code 3251 and 3252.The explanted devices were returned to w.L.Gore & associates for investigation.Submitted unfixed were two gore® viabahn® endoprostheses.The following abbreviations are used in the explant summary: lot 15582065 (catalog pah090502) = vbn-1 = mfr report #2017233-2019-00122.Lot 16155093 (catalog pah081002) = vbn-2 = mfr report #2017233-2019-00121.Vbn-1 was seated within vbn-2, protruding 22 mm proximally.The albumen had multifocal to diffuse, scant, tan to brown/red friable material.The lumen had minimal to mild, multifocal, red/brown friable tissue present.The lumen was largely occluded with red/brown, friable material at the distal end, extending 40 mm.Both vbn-1 & vbn-2 had transverse transections, prior to arrival.There were multiple wire discontinuities observed on vbn-2 in an area of anatomical bend, starting just distal from where vbn-1 ended inside the lumen.Histopathologic analysis was not performed, due to paucity of tissue and lack of fixation prior to arrival at w.L.Gore & associates.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the devices were examined for material disruptions with the aid of a stereomicroscope and scanning electron microscope (sem) imaging.Vbn-1 was ovular in shape with two rows of ¿running¿/consecutive wire discontinuities present on opposing sides of the device, extending 43 and 40 mm from the distal end, respectively.On vbn-1, a total of 47 wire discontinuities were present.A total of five puncture wear-related holes in the graft material were present in the area of wire discontinuities.The holes were consistent with those caused by puncture from a broken stent frame.A total of 22 wire discontinuities were present on vbn-2.All but three of the wire discontinuities were in alignment with the two opposing wire discontinuity rows of vbn-1.Of the three, two of the wire discontinuities were within two stent rows of the area of device overlap.A total of 33 wear-related holes were present; 21 frictional, 10 stent frame punctures and 1 stretch-flexion.The frictional holes had characteristics consistent with blunt abrasion of the material, in-vivo (i.E., material smearing, bunching, material plowing and/or material transfer to underside of the stent).Of the 21 frictional holes, 17 were toward the distal end of the device, where the devices did not overlap.The stent frame puncture holes were consistent with those caused by a puncture from a broken stent frame.The stretch-flexion hole had characteristics consistent with graft material bring compressed and longitudinally flexed (i.E., surrounding compressed material, appearance of being pulled).The stretch-flexion hole was located on the edge of the overlapping devices.Representative wire specimens were collected for metallurgical analysis from both devices.The examined wire discontinuities exhibited characteristics consistent with fracture, due to cyclic fatigue loading.No evidence of corrosion or abnormal abrasion was observed on the nitinol wire.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8386420
• MDR Text Key: 137700506
• Report Number: 2017233-2019-00122
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2019
• Device Catalogue Number: PAH090502
• Device Lot Number: 15582065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention