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

Catalog Number PAH131002E

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).

Event Description

The patient was presented with an aneurysm in the left distal superficial femoral artery / proximal popliteal artery which was intended to be treated with two gore® viabahn® endoprostheses.Access was gained through the femoral artery by using an ipsilateral approach.It was stated that the first gore® viabahn® endoprosthesis could be inserted, advanced and deployed without any difficulties.It was reported to gore that when the second gore® viabahn® endoprosthesis was tried to be deployed, the first portion of deployment (about 5cm) could be performed without any abnormalities.It was stated that suddenly some resistance was experienced by pulling the deployment line further and that some significant friction was recognized.It was reported that further device deployment was continued step by step by pulling the deployment line centimeter by centimeter.The last portion of the device deployed suddenly without pulling the deployment line within the intended location.It was reported that when the deployment line was tried to be removed entirely from the delivery system some friction was experienced which resulted in a proximal movement of the endoprosthesis about 1 cm.Consequently, the desired overlap of the two implanted gore® viabahn® endoprostheses were shorter than expected.The patient is doing well following the procedure.

Manufacturer Narrative

(b)(4).Three time-points available for evaluation; pre-implantation cta dated (b)(6) 2017, intra-operative angiogram dated (b)(6) 2017 and an angiogram dated (b)(6) 2017.On the pre-implantation cta images, there appears to be diseased vessel in the left sfa/ popliteal artery.Intra-operative angiogram images on (b)(6) 2017 appear to show device(s) implanted in the left sfa/ popliteal artery.Contrast appears to flow through the devices and distally.Angiogram images on (b)(6) 2017 appear to show contrast flowing through the previously implanted device(s).A guide wire is present, however, no additional devices can be identified on the (b)(6) 2017 imaging.Images provided do not allow for evaluation in relation to the reported event.The reported proximal movement of the gore® viabahn® endoprosthesis, occurred during the initial procedure.No reintervention has occurred.There was no death, serious deterioration of health or reportable malfunction; therefore this event was determined not reportable and this report will be retracted.

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7044548
• MDR Text Key: 92777455
• Report Number: 2017233-2017-00613
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P130006
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2020
• Device Catalogue Number: PAH131002E
• Device Lot Number: 17165237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2017
• 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: 76 YR
• Patient Weight: 89