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

Catalog Number FVL06100

Device Problems Positioning Failure (1158); Misfire (2532); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl06100 vascular stent graft allegedly experienced detachment, partial deployment and failure to deploy.This information was received from one source.The detachment, partial deployment and failure to deploy involved one patient with no patient consequence.The age, weight, and sex were not reported.

• 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: 8807972
• MDR Text Key: 151620307
• Report Number: 9681442-2019-00125
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741144981
• UDI-Public: (01)00801741144981
• 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: 07/19/2019

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: FVL06100
• Device Lot Number: ANBS2343
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/19/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1