Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 FVL06080
Device Problems Positioning Failure (1158); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the device was provided; therefore, a lot history review will be performed.The device was returned to the manufacturer for evaluation.One photo was also provided for review.The company is still investigating the issue at this time.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 vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model fvl06080 vascular stent graft allegedly experienced positioning failure and misfire.This information was received from one source.One patient was involved with no patient consequences.The (b)(6) year old female was (b)(6) kgs.
 
Manufacturer Narrative
H10: the lot number for the device was provided; therefore, a lot history review was performed.The device was returned for the evaluation.One photo was also provided for review.The investigating confirmed for partial deployment.A definitive root cause could not be determined.The device is labeled for single use.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.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model fvl06080 vascular stent graft allegedly experienced positioning failure and misfire.This information was received from one source.One patient was involved with no patient consequences.The 56 year old female was 72 kgs.
 
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 Key9955757
MDR Text Key187530477
Report Number9681442-2020-00111
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741144974
UDI-Public(01)00801741144974
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberFVL06080
Device Lot NumberANCP1432
Date Manufacturer Received06/19/2020
Patient Sequence Number1
-
-