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

Catalog Number FVL07060

Device Problems Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

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.Manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: a physical evaluation was not performed because the sample was not available.Two photos were provided which indicate the sheath fracture and stent was within the system.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore, previous investigations of similar complaints have been reviewed.Challenging placement site and patient anatomy may lead to the failure mode.Insufficient flushing of the device before use or inadequate accessories may be contributing factors to the reported issue.In this case, the lesion was not predilated.The system was flushed prior to use.The device was used to treat stenosis of the fistula which represents an off-label use.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 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 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 packaging pictograms indicate an introducer size of 8f and a 0.035" guidewire.The instructions for use states regarding the placement site: "for use in the iliac and femoral arteries".This case represents an off-label use of device.Device not returned.

Event Description

It was reported that during a stent placement through femoral artery, the device allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement through femoral artery, the device allegedly failed to deploy.The procedure was completed using another device.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 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: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation; however, photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2022), g3.H11: d4(medical device lot), h6(method, 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.

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: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot, previously.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 received.A physical evaluation was performed, the sheath was identified fractured from the swivel nut and the stent was not returned as part of the system.Additionally, it is not known at what point the stent was deployed and sheath was fractured and detached.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore, previous investigations of similar complaints have been reviewed.Challenging placement site and patient anatomy may lead to the failure mode.Insufficient flushing of the device before use or inadequate accessories may be contributing factors to the reported issue.In this case, the lesion was not predilated.The system was flushed prior to use.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 states 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 accessories the instruction for use state: 'a super stiff guide wire is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure.' 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.

Event Description

It was reported that during a stent placement through femoral artery, the device allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.

• 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 Key: 11522601
• MDR Text Key: 253192860
• Report Number: 9681442-2021-00159
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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 Number: FVL07060
• Device Lot Number: ANDX5094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 04/13/2021; 05/31/2021
• Supplement Dates FDA Received: 05/10/2021; 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 80