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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 FVL10100
Device Problems Difficult or Delayed Positioning (1157); Fracture (1260); Malposition of Device (2616); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.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: 01/2023).Device not returned.
 
Event Description
It was reported that during a stent placement procedure, the delivery system allegedly felt stiff and was not moving.Extreme resistance was felt after 1 cm of the stent was deployed initially.It was further reported that when the stent was being deployed, the catheter shaft allegedly broke.When the remaining stent was being deployed, the stent was slightly moved and was deployed with great difficulty.Another device was used to complete the procedure by overlapping the previous stent.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing related cause was considered, therefore, the lot history records have been 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: a physical evaluation was not performed because the sample was not available.Photos of the product were provided demonstrating sheath fracture after the event.Images demonstrating malposition or deployment action were not provided.The investigation is confirmed for the reported sheath fracture.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 instruction for use state that '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 instruction 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.' in regards to accessories the instruction for use state: '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 catheter tip is tapered to accommodate a 0.035 in.Guide wire.', the packaging labels indicate an introducer size of 9f.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 g5.H10: d4 (expiry date: 01/2023), g3.H11: h6 (result, conclusion).H11: section a through f ¿ the information provide by bd represents all 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 : device not returned.
 
Event Description
It was reported that during a stent placement procedure, the delivery system allegedly had difficulty to advance through the lesion.The health care provider was made an attempt to deploy the stent which experience difficulty; however, the stent was deployed and the sheath was allegedly fractured.It was further reported that another stent was used to cover the lesion that was intended to be covered by one stent.There was no reported patient injury.
 
Event Description
It was reported that during a stent placement procedure, the delivery system allegedly felt stiff and was not moving.Extreme resistance was felt after 1 cm of the stent was deployed initially.It was further reported that when the stent was being deployed, the catheter shaft allegedly broke.When the remaining stent was being deployed, the stent was slightly moved and was deployed with great difficulty.Another device was used to complete the procedure by overlapping the previous stent.There was no reported patient injury.
 
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 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: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was returned for evaluation.A physical evaluation was performed, sheath fracture can be identified.Photos of the product were provided demonstrating sheath fracture.Images demonstrating malposition or deployment action were not provided.An indication for a manufacturing related issue could not be found.Based on the information available, the investigation of the reported issue is closed with confirmed result for sheath fracture.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 state that '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.' in regards to accessories the instructions for use state: '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 catheter tip is tapered to accommodate a 0.035 in.Guide wire.', the packaging labels indicate an introducer size of 9f.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.
 
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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 Key11145214
MDR Text Key226314882
Report Number9681442-2020-20150
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,Followup
Report Date 05/31/2021
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 Health Professional
Device Catalogue NumberFVL10100
Device Lot NumberANEN3547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Initial Date Manufacturer Received 12/16/2020
Initial Date FDA Received01/11/2021
Supplement Dates Manufacturer Received02/05/2021
05/31/2021
Supplement Dates FDA Received03/04/2021
06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age15 YR
Patient Weight42
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