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

Catalog Number PAH131002E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results code: a review of the manufacturing records for the device verified the lot met all pre-release specifications.An engineering evaluation is currently in progress.

Event Description

On (b)(6) 2017, a patient was being treated for a left common iliac artery aneurysm with two gore® viabahn® endoprostheses with heparin bioactive surface.An aorfix endoprosthesis was utilized as a main body aortic component.The first viabahn was placed in the left common iliac artery and covered the left hypogastric artery.The second viabahn was used as a bridge between the aorfix and the first viabahn.The second viabahn was advanced through a 12fr cook high flex introducer sheath from the left brachial artery.Once the device was in the target location, the introducer sheath was pulled back until almost all of the endoprosthesis was exposed.The deployment was initiated slowly, without incident.Before the deployment reached the introducer sheath, deployment was stopped in order to pull the sheath back more.The deployment line was then pulled again, but it felt as if there was bowstringing, and the deployment line would not release.After pulling hard, the deployment line did release from the catheter, but the catheter could not be withdrawn.Some maneuvering was performed and eventually the entire catheter was removed.Since the proximal part of the viabahn remained constrained, the procedure was completed by placing a balloon expandable covered stent to secure the overlap between the aorfix endoprosthesis and the viabahn bridging component.It is not known whether any deployment line fragments remain in the patient, however the patient did well following the procedure.

Manufacturer Narrative

The delivery catheter, the deployment knob and the deployment line were received with no endoprosthesis returned.The engineering evaluation stated that approximately 172 cm of the deployment line was connected to deployment knob, with a fiber extending 8 cm further.The end deployment line fibers appeared broken and frayed.Based on the engineering evaluation performed, no manufacturing anomalies were identified.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6986138
• MDR Text Key: 91221610
• Report Number: 2017233-2017-00566
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

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: 05/31/2020
• Device Catalogue Number: PAH131002E
• Device Lot Number: 16597048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR