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

Catalog Number VBJR051002A

Device Problem Activation Problem (4042)

Patient Problem Occlusion (1984)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records indicated the device met pre-release specifications.Examination of the returned device revealed the following: the entire device was returned with an introducer sheath; the introducer sheath was not evaluated as it is not a gore device; there was approximately 147 cm of deployment line between the hub and deployment knob; there was approximately 2 cm of endoprosthesis coming out of the introducer sheath; approximately 0.5 cm of the endoprosthesis was constrained by the constraining line while approximately 1.5 cm was expanded; there was approximately 7 cm of deployment line coming off of the constrained section of endoprosthesis with a 5 cm single fiber coming off of the end of the deployment line; the endoprosthesis appeared to be damaged with body delamination in the body of the endoprosthesis; the remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.There appeared to be cessation of initiated distal expansion with the inability to complete full expansion.Therefore this event will be considered a reportable malfunction.

Event Description

The following was reported to gore: when the deployment line of the gore® viabahn® endoprosthesis was pulled, nothing happened.Another gore® viabahn® endoprosthesis was successfully used to complete the case.

Manufacturer Narrative

Additional manufacturer narrative: b7: other relevant history, including preexisting medical conditions g5: combination product.G5: pre-1938.G5: otc product.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9177182
• MDR Text Key: 195951700
• Report Number: 2017233-2019-01003
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623914
• UDI-Public: 00733132623914
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Catalogue Number: VBJR051002A
• Device Lot Number: 20719062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1