MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Catalog Number	FEM12100
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a stent graft placement procedure in the left forearm, a foreign body was allegedly found under x-ray examination.Reportedly, the patient had to have the vein removed.The current status of the patient is unknown.
Additional Manufacturer Narrative
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, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2025) h11: section a through f ¿ the information provided 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 or Problem Description
It was reported that during a stent graft placement procedure in the left forearm, a foreign body was allegedly found under x-ray examination.Reportedly, the patient had to have the vein removed.The current status of the patient is unknown.
Additional Manufacturer Narrative
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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: a stent delivery system was returned for evaluation.The stent graft was completely deployed and missing upon sample receipt.The tip of the distal end of the outer sheath including the radiopaque marker of the delivery system was broken off and not returned.An x-ray provided shows a stent placed in the patient¿s vessel, with a foreign object constricting the end of the stent graft.A foreign object was found in the patients¿ vessel, post stent placement.Based on the condition of the sample it is reasonably suggested that the foreign object is the broken tip of the outer sheath.Based on an x-ray images provided the segment of the outer sheath got initially stuck on the implanted stent.An alleged damage of the distal end of the outer sheath and a subsequent break may be related to insufficient flushing of the device prior to use or use of inadequate accessories, such as an introducer sheath.A difficult patient anatomy or a challenging placement site may be other contributing factors.The stent was intended to be placed to treat an extravasation in the left forearm.As reported an 8f and 11f sheath, and hydrophilic guidewires were used.Based on the investigation completed the distal tip of the outer sheath is confirmed to be broken off and detached inside the patient.However, a definite root cause for the reported event could not be determined.The reported use of the device represents an off label use.Labeling review: relevant labeling was reviewed and the instruction for use was found to address the potential risk.The instruction for use states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device." regarding preparation of the device the instruction 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 accessories the instruction for use states: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended." "in the case of in-stent restenosis, post dilation of the stent graft must be performed with a pta balloon catheter no larger than the previously placed bare metal stent." the intended use of the device to treat an extravasation represents an off label use.Based on the instruction for use supplied with this product the fluency® plus endovascular stent graft is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an av graft.H10: d4 (expiry date: 12/2025), g3, h6 (device, method).H11: e1, h6 (result, conclusion).H11: section a through f ¿ the information provided 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 : see h10.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• 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 Key: 18490671
• Report Number: 2020394-2023-01384
• Device Sequence Number: 17027715
• Product Code: PFV
• UDI-Device Identifier: 04049519008660
• UDI-Public: (01)04049519008660
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: FEM12100
• Device Lot Number: ANGZ1314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Race: Asian