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

Model Number	FEM10060
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.Neither the device nor medical records have been returned for evaluation, therefore, the investigation is inconclusive for obstruction of flow as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
It was reported that after a stent graft placement in a left upper arm fistula, the stent graft allegedly occluded.It was further reported that the patient was hospitalized and an additional declot procedure was required to restore patency.The patient is reportedly stable.

• 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: 9357158
• Report Number: 2020394-2019-04824
• Device Sequence Number: 14118167
• Product Code: PFV
• UDI-Device Identifier: 04049519008592
• UDI-Public: (01)04049519008592
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: FEM10060
• Device Catalogue Number: FEM10060
• Device Lot Number: ANDR0786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 59