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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient presented with an aneurysm within the popliteal artery which was intended to be treated with two gore® viabahn® endoprostheses on (b)(6) 2017.It was stated that a 5mm x 10cm device was implanted at the distal end of the aneurysm and a 6mm x 10cm device implanted at the proximal end.After both medical devices have been implanted successfully, with an appropriate overlapping and good blood flow, the patient was discharged from the hospital.On (b)(6) 2018, the patient presented with pain in the treated leg where a performed angiography indicated a migration of the two implanted gore® viabahn® endoprostheses for about 3 cm distal.It was reported to gore that due to the device migration, the distal gore® viabahn® endoprosthesis covered the anterior tibial artery which resulted in a major thrombosis of the patients leg.An attempt was made to perform a recanalization of the thrombus which resulted in an open surgery where the distal implanted gore® viabahn® endoprosthesis was removed from the artery and the treatment was completed by performing a bypass procedure.It was stated that the patient was doing well following the procedure.

Manufacturer Narrative

Engineering evaluation: an expanded gore® viabahn® endoprostheses was returned and evaluated.The endoprosthesis measured approximately 8.4 cm in length and 0.5 cm in diameter.The distal (straight) end of the endoprosthesis appeared to have some delamination of the graft from the stent.It also appears that the distal stent row is folded into graft.After pulling the inverted part out, it was able to be seen that there was an incomplete stent row.It appeared that the straight end of the stent graft had been cut/ripped.Based on the device examination performed, no manufacturing anomalies were identified.

Manufacturer Narrative

Added conclusion code (b)(4).

Manufacturer Narrative

An explant evaluation was performed for the 5mm x 10cm gore® viabahn® endoprosthesis, which was implanted at the distal end of the aneurysm and which migrated for about 3 cm resulted in a covered the anterior tibial artery and consequently caused a thrombosis of the patients leg.Submitted unfixed and devoid of tissue was one gore® viabahn® endoprosthesis fragment.The lumen of the device was widely patent.One pole was transected prior to arrival, with graft material and wire missing.Histopathological examination was not performed due to the paucity of adherent tissue.The device fragment was subjected to an enzymatic digestion process to remove biologic debris.Following digestion the fragment was examined for material disruptions with the aid of a stereomicroscope.The device was transected at the distal end with the ptfe presenting unevenly discontinuous and bound by smooth edges and the stent frame surface had disruptions (e.G., scratches) and faces of the wire ends were markedly angled: these disruptions are consistent with the use of a sharp surgical instrument likely used during the surgical explant process (e.G., scissors).No wear related disruptions were identified.The previous reported coding remains the unchanged based on the investigations results.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7543649
• MDR Text Key: 109227562
• Report Number: 2017233-2018-00304
• 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
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/28/2018; 02/18/2019; 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR