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

Model Number	FEM14060
Medical Device Problem Codes	Positioning Failure (1158); Material Perforation (2205); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during a stent deployment procedure in the cephalic arch, allegedly there was difficulty advancing the delivery system to the target lesion.Reportedly, the device would not deploy.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.No additional complaint has been reported for this lot number previously.Investigation summary: based on the returned stent graft delivery system, the alleged deployment failure could be confirmed.The outer sheath was found to be elongated and one strut perforated through the catheter wall, which indicated that high deployment forces were present during the attempt to deploy the stent graft.Subsequently this made further deployment of the stent graft impossible.No indication for a manufacturing related cause could be found.Conclusion: as a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.(b)(4).
Event or Problem Description
It was reported that during a stent deployment procedure in the cephalic arch, allegedly there was difficulty advancing the delivery system to the target lesion.Reportedly, the device would not deploy.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6881522
• Report Number: 2020394-2017-01177
• Device Sequence Number: 116143
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2020
• Device Model Number: FEM14060
• Device Catalogue Number: FEM14060
• Device Lot Number: ANBN0237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 109