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

Catalog Number FVL06080

Device Problems Fracture (1260); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.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 endovascular stent graft products that are cleared in the us.The pro code for the products is identified.

Event Description

This reported summarizes one malfunction.A review of the reported malfunction indicated that model fvl06080 vascular stent graft allegedly experienced fracture and misfire.This information was received from one source.The malfunction involved a patient with no reported consequences.The patient weighed (b)(6) kgs; age and gender were 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: 9957290
• MDR Text Key: 187718893
• Report Number: 9681442-2020-00116
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741144974
• UDI-Public: (01)00801741144974
• 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

• 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: ANBP0282
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1