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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVL12030
Device Problems Positioning Failure (1158); Retraction Problem (1536); Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified.(expiry date: 08/2021).
 
Event Description
It was reported that during the stent graft placement through right femoral artery, the device allegedly failed to deploy and had a retraction problem.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during the stent graft placement through right femoral artery, the device allegedly failed to deploy and had a retraction problem.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 returned for evaluation.Based on the investigation performed in the laboratory the stent could not be deployed and was found perforating the tip.A 'failure to deploy' issue is confirmed as well as the cascading event 'material perforation'.A 'retraction problem' could not be confirmed.No manufacturing issues were identified.Insufficient flushing of the device before use or inadequate accessories may be contributing factors to the reported issue.It is only known that the stent was placed straight, but not if the proximal end of the stent was straight upon deployment.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use states: 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.' regarding accessories the instructions for use states: 'a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure'; the packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.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 products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.H10: d4 (expiry date: 08/2021), g3, h6 (device).H11: h6 (method, result, conclusion).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.H3 other text : see h10.
 
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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
MDR Report Key12049371
MDR Text Key257758776
Report Number9681442-2021-00374
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFVL12030
Device Lot NumberANCV3755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Date Manufacturer Received09/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient Weight55
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