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

Catalog Number FVL14040

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for the reported stent tip damage.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl14040 vascular stent graft allegedly had stent tip damage.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.The female patient is(b)(6) and weight 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11197560
• MDR Text Key: 228707565
• Report Number: 9681442-2021-80002
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145339
• UDI-Public: (01)00801741145339
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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: ANDN2006
• Date Manufacturer Received: 12/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1