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

Catalog Number VBH061002W

Device Problems Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot/serial: 16249895 = udi: (b)(4).The concomitant medical product was a gore® viabahn® endoprostheses (vbh061502w/15985972).The therapy date was (b)(6) 2017.Udi information of the concomitant medical product as following.Lot/serial: 15985972 = udi: (b)(4).The review of the manufacturing records verified that this lot met all pre-release specifications.

Event Description

It was reported to gore that the patient had a left femoro-popliteal artery aneurysm and was to be implanted with gore® viabahn® endoprothesis for treatment.A 6mm x 15cm gore® viabahn® endoprothesis was accessed from the right femoral artery and advanced by crossover technique with help of a long sheath to the left side, however due to the serious tortuous anatomy of left external iliac artery, the device could not be further advanced to the target lesion and stuck in the femoro-popliteal artery, the physician changed different guide wires for attempt but still failed, so decided to retracted this viabahn device.A resistance was felt during retraction but still could be able to retract out of the patient through the sheath.A 6mm x 10cm gore® viabahn® endoprothesis was used and advanced from the same access, but was also stuck in the femoro-popliteal artery, so the physician retracted the viabahn® device through the sheath again.However after retraction out of the patient, the endoprothesis was observed in partial expansion about 5cm even the deployment knob was never not pulled, and the catheter looked a little bit thin and long in the middle portion.The third gore® viabahn® endoprothesis was used to continue the procedure.The physician tried an access by retrograde puncture from the lower limb to access the device.With help from a stretch guidewire, this gore® viabahn® was successfully advanced to the target lesion and deployed.

Manufacturer Narrative

An engineering evaluation for the returned device has been performed.The investigation stated that the deployment line appeared taut within hub.Approximately 0.3 cm of the distal shaft was exposed at the tip-end.There was a kink in distal shaft at transition.The inner braided constraining line was deployed, leaving approximately 5.8 cm of the endoprosthesis expanded.At 61 cm from the hub, there was approximately 12 cm of columnar failure of the dual lumen catheter shaft.Based on the device examination 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: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7227000
• MDR Text Key: 98646260
• Report Number: 2017233-2018-00059
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/31/2018

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: 11/22/2019
• Device Catalogue Number: VBH061002W
• Device Lot Number: 16249895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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: 70 YR