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

Model Number	VBJR051502A
Medical Device Problem Codes	Activation Failure (3270); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: the gore® viabahn® endoprosthesis (viabahn) was tracked through a 6fr terumo sheath over a terumo advantage.018 wire from a contra lateral approach into the left sfa.The lesion was mid to distal sfa.The doctor pre-dilated with a 3x80 ultraverse®.018 balloon.The viabahn was positioned with a 1cm overlap into a previously placed 5x5 viabahn.On deployment, the deployment line was pulled and almost half of the implant deployed when the deployment line broke.The proximal half of the viabahn was observed to be undeployed in patient.The hub of viabahn was cut off and a longitudinal cut made into the viabahn catheter to expose the deployment line, however, no line was there.The doctor attempted to move the catheter back and forth but the patient felt pain in the leg.So the procedure was converted to open bypass to remove device.The doctor opened the ipsilateral groin.He then took an 11 blade and cut open the 6fr sheath and the viabahn catheter, found the deployment line, which was frayed, and pulled it until it all came out.The tech walked back the catheter out of the body on the contra side then removed the sheath, the doctor cut the wire and placed a terumo 6fr x 10 short sheath thru the arteriotomy and ligated above.The doctor took a pic and the viabahn appeared deployed.He then put a 4x150 balloon down to post-dilatate and took a pic.The results appeared good, with 3 vessel runoff and palpable pulses.The cut catheter as well as the frayed deployment line is available for examination.
Additional Manufacturer Narrative
Corrected data: h6.Method code 2.H6.Results code 2.H6.Conclusions code 1.Additional manufacturer narrative: the deployment line was returned and examined.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
Additional Manufacturer Narrative
Additional manufacturer narrative: d6: if implanted, give date.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9440190
• Report Number: 2017233-2019-01227
• Device Sequence Number: 11339265
• Product Code: PFV
• UDI-Device Identifier: 00733132623921
• UDI-Public: 00733132623921
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2020
• Device Model Number: VBJR051502A
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 17430187
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/24/2020; 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR