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

Catalog Number FVL06080

Device Problems Positioning Failure (1158); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the u.S.But, it is similar to the fluency plus vascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus vascular stent graft products are identified.For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Fracture and positioning failure was confirmed for the device.A root cause has not been determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl06080 vascular stent graft allegedly experienced fracture and positioning failure.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is (b)(6) years old, male and (b)(6) kgs.

• 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: 9957292
• MDR Text Key: 187730290
• Report Number: 9681442-2020-00114
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145292
• UDI-Public: (01)00801741145292
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVL06080
• Device Lot Number: ANBX0484
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1