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

Model Number	FEM14060
Medical Device Problem Codes	Material Perforation (2205); Misfire (2532)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device is pending return.The investigation is currently underway.
Event or Problem Description
It was reported that during an endovascular stent graft placement procedure in the subclavian vein, resistance was felt during an attempt to deploy the stent graft.Therefore, the stent graft with the delivery system were removed and after removal, the stent graft strut allegedly had perforated the catheter.Reportedly, the patient will be return for another procedure at a later date.The patient is currently doing well.
Additional Manufacturer Narrative
H10: manufacturing review: the device and 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.A manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.Investigation summary: based on the investigation of the returned delivery system it was confirmed that the user could only partially deploy the stent graft.The deployment mechanism was found in used condition, and one stent graft strut was found perforating the outer sheath in the tip section which made a complete stent graft deployment impossible.Based on information available the investigation confirmed the alleged issue.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential factors.The ifu states: 'prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment.' furthermore, the ifu states: '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 higher deployment forces and possible endovascular system failure.', under materials required the ifu state: 'introducer sheath with appropriate inner diameter', and the packaging labels indicate a minimum introducer size of 10f.Furthermore, the ifu state: '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.' 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.
Event or Problem Description
It was reported that during an endovascular stent graft placement procedure in the subclavian vein, resistance was felt during an attempt to deploy the stent graft.Therefore, the stent graft with the delivery system were removed and after removal, the stent graft strut allegedly had perforated the catheter.Reportedly, the patient will be return for another procedure at a later date.The patient is currently doing well.

• 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
• MDR Report Key: 9234328
• Report Number: 2020394-2019-04312
• Device Sequence Number: 2233418
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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 Expiration Date: 05/31/2022
• Device Model Number: FEM14060
• Device Catalogue Number: FEM14060
• Device Lot Number: ANDS4402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 91