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

Catalog Number FVL12100

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified is not been cleared in the us, but is similar to the fluency endovascular stent graft that is cleared in the us.The pro code for the fluency endovascular stent graft is identified.The lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.The catheter sample, guidewire, and introducer sheath were not available for evaluation, and images have not been provided.The alleged issue could not be re produced which led to an inconclusive evaluation result.Based on the information available a definite root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model fvl12100 vascular stent graft allegedly was stuck on the guidewire and introducer sheath and was removed as one unit.The delivery system damaged the guidewire coating which led to the guidewire becoming stuck.There was no reported patient injury.This information was received from one source.The age, weight, and gender of the patients was not provided.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8794656
• MDR Text Key: 151285663
• Report Number: 9681442-2019-00102
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145308
• UDI-Public: (01)00801741145308
• 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: 07/16/2019

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: FVL12100
• Device Lot Number: ANBW0137, ANBX0486
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/16/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1