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

Catalog Number FVL14040

Device Problems Break (1069); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Based on the information available, the reported issue was confirmed.However, a definite root cause for the reported event could not be determined.The reported application represents an off-label use of the device.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl14040 vascular stent graft allegedly experienced a break, detachment of device or device component, and a failure to expand.This information was received from a single source.The alleged break, detachment of device or device component, and failure to expand involved a patient with no known impact to the patient.The patient is a 56-year-old male, weighing 78kg.

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation and images have been received; the investigation is confirmed for the reported break, detachment, and failure to expand.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl14040 vascular stent graft allegedly experienced a break, detachment of device or device component, and a failure to expand.This information was received from a single source.The alleged break, detachment of device or device component, and failure to expand involved a patient with no known impact to the patient.The patient is a 56-year-old male, weighing 78kg.

• 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: 8817081
• MDR Text Key: 151894494
• Report Number: 9681442-2019-00135
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145339
• UDI-Public: (01)00801741145339
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVL14040
• Device Lot Number: ANCY0417
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1