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

Catalog Number FVL12080

Device Problems Positioning Failure (1158); Material Perforation (2205); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

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 for evaluation.Therefore, the investigation is confirmed for the alleged partial deployment, material perforation and positioning failure issue.Based on the available information, the definitive root cause 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 endo vascular stent graft products that are cleared in the us.The pro code for the fluency plus endo vascular stent graft products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl12080 vascular stent graft allegedly experienced partial deployment, positioning failure and material perforation.This information was received from a single source.This malfunction involved patient with no reported consequences.The male patient is (b)(6) years old and weighs (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: 11200858
• MDR Text Key: 227783675
• Report Number: 9681442-2021-80001
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVL12080
• Device Lot Number: ANEP3786
• Date Manufacturer Received: 12/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1