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

Model Number FEM12080

Device Problems Material Perforation (2205); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Two lot numbers were reported for the two malfunctions and lot history reviews were performed.The devices were returned for both malfunctions, and one also returned an x-ray image.One malfunction confirmed for misfire and material perforation.The second malfunction identified material perforation.A root cause could not be determined.The devices are labeled for single use.

Event Description

This reported summarizes two malfunctions.The malfunctions were reviewed and indicated that model fem12060 endovascular stent graft allegedly experienced misfire and material perforation.This information was received from various sources.The malfunctions involved both patients with no known impact to the patients.One patient was (b)(6) year old male weighing (b)(6) kgs.The second patient was (b)(6) year old male weighing (b)(6) lbs.

• Brand Name: FLUENCY PLUS ENDVASCULAR STENT GRAFT
• Type of Device: ENDVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9957287
• MDR Text Key: 187714124
• Report Number: 2020394-2020-02650
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008653
• UDI-Public: (01)04049519008653
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2020

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: No Information
• Device Model Number: FEM12080
• Device Catalogue Number: FEM12060
• Device Lot Number: ANDU3006, ANDR1785
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1