MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT

Catalog Number FVL14120

Device Problems Positioning Failure (1158); Misfire (2532); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, the fvl14120 vascular stent graft was returned to the manufacturer for evaluation.A device history review was performed.The investigation identified both product problems.The investigation was not able to determine a root cause.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the event indicated that model fvl14120 experienced a misfire and material deformation.This report was received from one source.The device was used in the patient.Patient age, weight, and gender were not provided.There was no reported patient injury.

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Misfire and material deformation was confirmed for the device.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the event indicated that model fvl14120.Vascular stent graft experienced a positioning failure, misfire and material deformation.This report was received from one source.The device was used in the patient.Patient age, weight, and gender were not provided.There was no reported patient injury.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8808386
• MDR Text Key: 151630866
• Report Number: 9681442-2019-00129
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145377
• UDI-Public: (01)00801741145377
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

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 Catalogue Number: FVL14120
• Device Lot Number: ANCU2457
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/22/2019
• Patient Sequence Number: 1