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 Codes	Extravasation (1842); Rupture (2208)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a stent placement procedure to treat a clotted access in the left upper arm fistula, the deployed stent graft allegedly led to an extravasation of the surrounding vessel.The device was remained in the patients vessel and an additional device was used to stop the extravasation.Patient has no post-procedural issues.
Additional Manufacturer Narrative
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 pictures confirm a deployed stent with an extravasation in the surrounding vessel.A damage or deformation potentially leading to the issue could not be identified although the resolution of the image is poor.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 inconclusive for the reported device issue due to a lack of sufficient information.A definite root cause for the reported event could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use (ifu) 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.' (expiry date: 09/2024).
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: the sample was not returned to the manufacturer for evaluation.The pictures confirm a deployed stent with an extravasation in the surrounding vessel.A damage or deformation potentially leading to the issue could not be identified although the resolution of the image is poor.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 inconclusive for the reported device issue due to a lack of sufficient information.A definite root cause for the reported event could not be determined based upon the available information.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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a stent placement procedure in the left upper arm fistula, the device was allegedly appeared to excess after seating the stent.Reportedly, the device caused the extravasation at the very end post placement and caused rupture in vessel.The procedure was completed using another device.The patient reported to be stable.
Event or Problem Description
It was reported that during a stent placement procedure in the left upper arm fistula, the device was allegedly appeared to excess after seating the stent.Reportedly, the device caused the extravasation at the very end post placement and caused rupture in vessel.The procedure was completed using another device.The patient reported to be stable.
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: the sample was not returned to the manufacturer for evaluation.The pictures confirm a deployed stent with an extravasation in the surrounding vessel.A damage or deformation potentially leading to the issue could not be identified although the resolution of the image is poor.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 inconclusive for the reported device issue due to a lack of sufficient information.A definite root cause for the reported event could not be determined based upon the available information.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.H3 other text : device not returned.

• 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: 14489664
• Report Number: 2020394-2022-00404
• Device Sequence Number: 12105564
• 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,Followup
• Report Date (Section B): 06/21/2022

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: ANFW2963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 06/15/2022; 06/21/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/17/2022; 06/24/2022
• 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