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

Model Number FEM10040

Device Problems Difficult to Remove (1528); Material Perforation (2205); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the manufacturer for evaluation.The lot number was provided and device history review performed.It was observed that the stent graft was partially deployed and one strut perforated the tip.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem10040 endovascular stent graft allegedly experienced a material perforation and a misfire.This information was received from a single source.The alleged a material perforation and misfire involved a patient with no known impact to the patient.The patient is a (b)(6) -year-old male; weight was not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem10040 endovascular stent graft allegedly experienced a material perforation, difficulty to remove, and a misfire.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient is a 39-year-old male; weight was not provided.

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation.The investigation is confirmed for material perforation, misfire, and difficulty to remove.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8805694
• MDR Text Key: 151608782
• Report Number: 9681442-2019-00118
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008585
• UDI-Public: (01)04049519008585
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FEM10040
• Device Catalogue Number: FEM10040
• Device Lot Number: ANCX2558
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1