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

Model Number	VBH131002A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A direct product analysis is ongoing.
Event or Problem Description
It was reported to gore: on (b)(6) 2020 a patient was being treated for a left popliteal sfa cut down using a gore® viabahn® endoprosthesis (viabahn), through a medtronic 12fr sheath.The physician pre-dilated the treatment area.While the physician was advancing the delivery system to the treatment area he noticed the radiopaque markers were off by approximately 2 cm.The fsa then suggested the physician retrieve the device.The physician carefully and slowly removed the device.When the device was cleared of the patient it was noted that the device was sliding freely on the catheter.The physician noted he felt a slight resistance at first, however he thought the resistance was due to the patient's tortuous anatomy.The procedure was completed using another viabahn of the same size.The patient tolerated the procedure and is doing well.The device is available for return, a histo kit has been requested.
Additional Manufacturer Narrative
Additional manufacturer narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #18231447.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Additional Manufacturer Narrative
Corrected data: h6.- results code 1.Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.
Additional Manufacturer Narrative
Corrected data: h6.- results code 2.Additional manufacturer narrative: examination of the returned device revealed the following: the entire device was returned; approximately 1.7 cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed near the tip end of the device; the endoprosthesis was longitudinally compressed towards the transition; the endoprosthesis also had outwardly flared struts in the first strut row; the outer braided constraining line was deployed approximately 0.9 cm; the remainder of the endoprosthesis was still constrained by the inner braided constraining line.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10176828
• Report Number: 2017233-2020-00445
• Device Sequence Number: 14123550
• Product Code: PFV
• UDI-Device Identifier: 00733132623297
• UDI-Public: 00733132623297
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/06/2020

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: 04/18/2021
• Device Model Number: VBH131002A
• Device Catalogue Number: VBH131002A
• Device Lot Number: 18231447
• 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; Not provided
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/15/2020; 07/31/2020; 08/10/2020
• 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: Other
• Patient Age: 74 YR