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

Catalog Number VBJR062502A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

Review of device manufacturing record history confirmed device met all pre-release specifications.Returned device is currently in evaluation.Instructions for use (ifu) directions for use state: while maintaining the position of the guidewire across the treated lesion, carefully withdraw the delivery catheter through the lumen of the endoprosthesis and remove it via the introducer sheath.Moderate resistance may be felt when the distal tip is withdrawn through the introducer sheath.Note: if, during catheter removal, the tip catches on the leading edge of the endoprosthesis or introducer sheath, a slight ¿back and forth¿ motion of the catheter or repositioning of the sheath may aid in release.Excessive or abrupt force during catheter removal may damage the endoprosthesis, delivery catheter, or introducer sheath.

Event Description

The following was reported to gore: patient presented for femoral artery and angioplasty procedure due to progressing superficial femoral artery disease.Access was gained from the contralateral leg.A 6fr cook sheath was used to advance a gore® viabahn® endoprosthesis over a svs cordis guidewire.The viabahn device reached the intended treatment site and was deployed with no issues.As the catheter was being withdrawn, the catheter was pulled with force because strong resistance was encountered.The catheter broke and two-thirds of it was removed.Next, the sheath rest of the catheter were removed together.It was realized the distal tip of the catheter had gotten hung up on the edge of the sheath when catheter appeared to be stuck.A new sheath was placed and additional devices were placed to complete the procedure with no harm to the patient.

Manufacturer Narrative

Copy of user facility medwatch report received on october 2, 2018 has been attached.

Event Description

Event description from user facility states, elderly male was undergoing a femoral artery angioplasty procedure with stent placement.The device was deployed in iliac artery successfully.However, upon retrieval of the deployment portion of the device, the device broke.The surgeon was able to remove the broken piece without harm to the patient.

Manufacturer Narrative

Code 213: the following observations were made by the engineering evaluation: the endoprosthesis, deployment line, and deployment knob were not returned.The delivery catheter appeared broken or cut into multiple pieces.An introducer sheath was returned in two pieces.It was not evaluated as it is not a gore device.The dual lumen catheter shaft measures 90 cm from the hub to the broken/cut end.The distal tip was returned with 24.7cm of distal shaft connected to it.The transition end of the distal shaft and remainder of dual lumen was not returned.Based on the device examination performed, no manufacturing anomalies were identified.Gore received a copy of voluntary medwatch report submitted by user facility.Updated fields are: patient's weight is 77 kg; ethnicity is black/african american; patient age was listed as 70 years which does not correlate to dob initially provided; event description from voluntary medwatch report submitted by user facility.Patient history from voluntary medwatch report submitted by user facility.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7954780
• MDR Text Key: 123941989
• Report Number: 2017233-2018-00607
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623976
• UDI-Public: 00733132623976
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

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: 01/02/2021
• Device Catalogue Number: VBJR062502A
• Device Lot Number: 17875464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2018; 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6FR COOK SHEATH, SVS CORDIS GUIDEWIRE
• Patient Age: 70 YR
• Patient Weight: 77