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

Catalog Number FVL14080

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)

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 fvl14080 vascular stent graft allegedly experienced difficulty deploying and malposition of device.This information was received from one source.The difficulty deploying and malposition of device involved one patient with no patient consequence.The age, weight, and sex were not reported for the patient involved.

• 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: 8795063
• MDR Text Key: 151191030
• Report Number: 9681442-2019-00105
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145353
• UDI-Public: (01)00801741145353
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVL14080
• Device Lot Number: ANCZ2839
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1