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

Catalog Number	VBJR081002A
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.Examination of the returned device revealed the following: the endoprosthesis was returned with sutures attached to the contoured end of the endoprosthesis; the sutures were not evaluated as they are not a gore device; a part of the deployment line was stuck to the endoprosthesis 6 cm from the straight cut end of the endoprosthesis with single fibers coming off of the deployment line that measured 1 and 14 cm; the endoprosthesis was fully expanded with the contoured end of the endoprosthesis compressed and damaged possibly due to the sutures.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore: the gore® viabahn® endoprosthesis was placed in the sma as a snorkel.When the doctor began pulling the deployment line the device opened approximately 1/2 and stopped opening.The distal end of the device had opened but the proximal end never opened.The doctor advanced the sheath over the device and attempted to remove the device.The attempt moved the device into the subclavian artery where the device was eventually pulled from the patient.The doctor surgically repaired the artery.
Additional Manufacturer Narrative
Correction: adverse event and/or product problem.Describe event or problem.
Event or Problem Description
The following was reported to gore: the gore® viabahn® endoprosthesis was placed in the sma as a snorkel.When the doctor began pulling the deployment line the device opened approximately 1/2 and stopped opening.The distal end of the device had opened but the proximal end never opened.The doctor advanced the sheath over the device and attempted to remove the device.The attempt moved the device into the subclavian artery where the device was eventually pulled from the patient.Another gore® viabahn® endoprosthesis was successfully used to complete the treatment.The doctor closed the artery in the normal fashion with no serious injury to the patient.
Additional Manufacturer Narrative
Corrected date: describe event or problem.
Event or Problem Description
The following was reported to gore: the gore® viabahn® endoprosthesis was placed in the superior mesenteric artery (sma) as a snorkel.When the doctor began pulling the deployment line the device opened approximately 1/2 and stopped opening.It is believed that the deployment line broke during this time.The distal end of the device had opened but the proximal end never opened.The doctor advanced the sheath over the device and attempted to remove the device.The attempt moved the device into the subclavian artery where the device was eventually pulled from the patient.Another gore® viabahn® endoprosthesis was successfully used to complete the treatment.The doctor closed the artery in the normal fashion with no serious injury to the patient.
Additional Manufacturer Narrative
Additional manufacturer narrative & corrected data: g4: date received by manufacturer (mm/dd/yyyy).
Additional Manufacturer Narrative
Corrected data: h1 - type of reportable event.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8584618
• Report Number: 2017233-2019-00322
• Device Sequence Number: 3236159
• Product Code: PFV
• UDI-Device Identifier: 00733132623822
• UDI-Public: 00733132623822
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 06/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2021
• Device Catalogue Number: VBJR081002A
• Device Lot Number: 18875353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• 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; Not provided
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/03/2019; 06/03/2019; 06/05/2019; 06/21/2019
• 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: 76 YR