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 FVL10040
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2022
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 05/2024).
 
Event Description
It was reported that during preparation of a stent placement procedure via common femoral artery, the stent delivery sheath was allegedly found to be broken.The procedure was completed using another device.There was no patient contact.
 
Event Description
It was reported that during preparation of a stent placement procedure via common femoral artery, the stent delivery sheath was allegedly found to be broken.The procedure was completed using another device.There was no patient contact.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation and photos were submitted, showing a contaminated fluency plus delivery system with a fractured outer sheath and a partially deployed stent graft.These conclusion and evaluation results do not fit the description that the damage was detected during preoperative inspection.Therefore the investigation is inconclusive for reported issue.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instructions for use states: "the sterile packaging and devices should be inspected prior to use.Verify that the packaging and the device are undamaged and that the sterile barrier is intact.If damaged, do not use." h10: d4 (expiry date: 05/2024), g3.H11: h6 (device, method).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
wachhausstr. 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM   76227
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key14494671
MDR Text Key292579601
Report Number9681442-2022-00159
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145216
UDI-Public(01)00801741145216
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFVL10040
Device Lot NumberANFS2322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexFemale
-
-