• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVL08080
Device Problems Positioning Failure (1158); Fracture (1260); Material Perforation (2205)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation; therefore, the investigation is inconclusive for the failure to deploy and fracture as no objective evidence has been provided to confirm any alleged deficiency with the vascular stent graft.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model fvl08080 vascular stent graft allegedly experienced a failure to deploy and a fracture.This information was received from a single source.The alleged failure to deploy and fracture involved a patient with no known impact to the patient.The patient is a (b)(6) -year-old male, weighing (b)(6) kg.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model fvl08080 vascular stent graft allegedly experienced a failure to deploy, a fracture, material perforation, and partial deployment.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient is a 79-year-old male, weighing 63kg.
 
Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was not returned for evaluation.However, based on a photo provided, it was confirmed that a strut perforated the distal end of the delivery systems catheter proximal to the marker which prevented complete deployment of the stent graft.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: b5; g4; h6 (device 2532- misfire).H11: g1; h6 (method, results).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key8794587
MDR Text Key151179468
Report Number9681442-2019-00100
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145117
UDI-Public(01)00801741145117
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/21/2019
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 NumberFVL08080
Device Lot NumberANCX1504
Initial Date Manufacturer Received 06/30/2019
Initial Date FDA Received07/16/2019
Supplement Dates Manufacturer Received09/30/2019
Supplement Dates FDA Received10/21/2019
Patient Sequence Number1
-
-