MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Model Number	BXA083902A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.
Event or Problem Description
The following was reported to the gore fsa from the doctor: the patient presented for left common iliac artery disease treatment.The gore® viabahn® vbx balloon expandable endoprosthesis was advanced to the lesion and deployed without issue.However, the balloon would not deflate.Several attempts to deflate the balloon were made via arm access first using a laser and then a biliary puncture needle without success.The doctor decided to inflate the balloon to 20 atmosphere which popped the balloon.The balloon was able to be removed at that time.The vessel was successfully relined with an 8x59 gore® viabahn® vbx balloon expandable endoprosthesis.The patient is fine.The balloon and catheter is available for examination.
Additional Manufacturer Narrative
H6.Results code 2.H6.Conclusions code 1.Additional manufacturer narrative: examination of the returned device revealed the following: -the gore® viabahn® vbx balloon expandable endoprosthesis was returned with the delivery system deployed and the balloon/balloon cover ruptured.-the delivery system was observed to have catheter damage in the form of necking at multiple points throughout the length of the delivery system catheter.Each delivery system balloon is 100% verified in process to inflate and deflate.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9740834
• Report Number: 2017233-2020-00122
• Device Sequence Number: 10851027
• Product Code: NIO
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2022
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Device Lot Number: 20931102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR