MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Model Number FEM09060

Device Problems Material Invagination (1336); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.

Event Description

It was reported that the stent allegedly partially deployed; therefore, the device was removed from the patient without incident.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the sample evaluation, a tip invagination could be confirmed.The distal tip was invaginated so that the inner catheter protruded from the tip.The deployment system was found to be functioning and during sample testing, the stent graft could be deployed without difficulty.A partially deployed stent graft could not be confirmed.As a result of the investigation performed, the complaint is confirmed for tip invagination.Based on the available information and the evaluation of the returned sample, a definite root cause for the reported failure could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding potential damages, the ifu states: "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed." regarding preparation of the device the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline." furthermore, the ifu states regarding the use of accessories: "materials required for the fluency® plus endovascular stent graft procedure: 0.035" (0.889 mm) guidewire introducer sheath with appropriate inner diameter." (eval code & desc - conclusion1).

Event Description

It was reported that the stent allegedly partially deployed; therefore, the device was removed from the patient without incident.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7318908
• MDR Text Key: 101857431
• Report Number: 2020394-2018-00201
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008547
• UDI-Public: (01)04049519008547
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

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: 09/22/2020
• Device Model Number: FEM09060
• Device Catalogue Number: FEM09060
• Device Lot Number: ANBW2763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 109