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

Model Number	FEM09060
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a stent placement procedure, the device was allegedly appeared to excess after seating the stent.It was further reported that device caused extravasation.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiration date: 12/2024).Device not returned.
Event or Problem Description
It was reported that during a stent placement procedure, the device allegedly caused extravasation.It was further reported that another stent was placed to line the original stent.The patient current status was 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 physical sample is not available for return.The provided images show a deployed stent and a suspected extravasation.A damage to the stent graft/struts potentially leading to vessel rupture or extravasation cannot be identified in the images.Based on the provided information, an extravasation of the vessel surrounding the stent graft can be confirmed.However there is no information to verify if the extravasation was caused by a deficiency of the stent graft.The investigation is therefore closed as inconclusive due to a lack of sufficient information.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.The instructions for use state: 'prior to stent graft deployment (.), ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible endovascular system failure.' the instructions for use also lists the following precaution: 'careful attention should be paid to ensure the device is appropriately sized to the achievable lumen, taking into account any change to the stated treatment area diameter that may have resulted from previous interventions'.A stent graft sizing table describes the appropriate oversizing of the stent graft in relation to the reference vessel diameter.Regarding pre-dilation it states 'pre-dilate the lesion and confirm that the stenosed lumen can be dilated to the desired diameter.In case of in-stent restenosis, the balloon diameter for pre-dilation should be no larger than the previously placed bare metal stent diameter.' 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.

• 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: 14494854
• Report Number: 2020394-2022-00407
• Device Sequence Number: 17601537
• Product Code: PFV
• UDI-Device Identifier: 04049519008547
• UDI-Public: (01)04049519008547
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/27/2022

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 Model Number: FEM09060
• Device Catalogue Number: FEM09060
• Device Lot Number: ANFZ2837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 66 KG