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

Catalog Number	FAS07070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the endovascular stent graft allegedly partially deployed and then would not deploy any further.It was further reported that the stent graft delivery system was removed from the patient and an alleged break in the outer catheter was identified.Reportedly, the health care provider concluded the procedure and the patient/procedure was to be rescheduled.There was no reported impact or consequence to the patient.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual inspection: the sample was returned.The safety clip was missing upon receipt.The tuohy borst valve was loose, the y-body was loose and not connected, and the two-way stop cock was opened.The outer catheter was noted to have a circumferential break 59mm from the strain relief with stretching noted around break.The stent graft was partially deployed and protruded approximately 13mm from the tip of the outer sheath.Bent struts were noted in the undeployed portion of the stent graft.A bend in the outer catheter was noted 58mm from the distal end of the outer cathether.Performance evaluation: functional testing could not be performed, as the delivery system was returned with the outer sheath broken.Medical records review: as medical records were not provided, a review could not be performed.Photo review: one digital photo was reviewed.The photo shows one outer grey catheter with a break approximately distal to the strain relief.The break is a complete circumferential break with apparent stretching to the catheter.The investigation can be confirmed for an outer catheter break from the provided photo.Conclusion: the investigation is confirmed for partial deployment, as the stent graft was returned partially deployed.It should be noted that an outer shaft break is also confirmed, as the outer sheath was torn off at the catheter reinforcement area.Per the reported event details, the physician did not use a sheath.The ifu states under ¿materials required for device placement¿ that a 9f introducer sheath is required for device placement.Therefore, it is possible that procedural issues contributed to the reported event.However, the definitive root cause could not be determined.Labeling review: the current ifu (instructions for use) state: indication for use: flair endovascular stent graft is indicated for use in the treatment at the venous anastomosis of eptfe or other synthetic arteriovenous (av) access grafts.Warnings: the stent graft (implant) cannot be repositioned after total or partial deployment.Once partially or fully deployed, the flair endovascular stent graft cannot be retracted or remounted onto the delivery system.Device removal after deployment can only be done with a surgical approach.Precautions: the safety and effectiveness of this device have not been established when used around a tight bend in a looped av graft.It is recommended to access the av graft at the venous side of the av graft or at the apex.Careful attention should be paid to ensure the device is appropriately sized to the actual graft diameter, taking into account any change to the stated graft diameter that may have resulted from previous interventions.The appropriate length device(s) should be selected so that the stent graft extends beyond the stenosis into at least 10 mm of the non-diseased graft towards the arterial inflow and into the non-diseased vein approximately 10 mm beyond the stenosis.During deployment of the stent graft, the entire length of the delivery system should be kept as straight as possible in order to mitigate the potential for distal stent graft misplacement.After full stent graft deployment, wait a few seconds to allow for complete device expansion before removing the delivery system over the guidewire.Stent graft dislodgement has been reported during removal of the delivery system; therefore, careful attention should be paid during this portion of the procedure to prevent such occurrences.In case of placement of two stent grafts (overlap), use the same device diameter in both cases.If a flared device is used to overlap, do not deploy the flared end inside the first stent graft.Ensure a minimum 10 mm overlap of the devices.Potential complications and adverse events: stent graft specific events that could be associated with clinical complications include stent graft misplacement, stent graft migration, stent graft fracture, stent graft kinking, insufficient stent graft expansion and stent graft embolism.Delivery system specific events that could be associated with clinical complications include bond joint failures, detachment of parts, incompatibility with accessory devices, premature deployment, inaccurate deployment, failure to deploy, high deployment forces, delivery system kinking, no visibility under fluoroscopy, inability to track to target location, and blood leakage from delivery system (hemostasis).Stent graft size selection: special care must be taken to ensure that the appropriate size flair endovascular stent graft is selected.The stent graft body diameter should be approximately 1 mm larger than the synthetic av access graft diameter.(b)(4).The information provided by bard 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 bard.

• Brand Name: FLAIR 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: 5665494
• Report Number: 2020394-2016-00452
• Device Sequence Number: 179581
• Product Code: MIH
• UDI-Device Identifier: 04049519008967
• UDI-Public: (01)04049519008967(17)180828(10)ANZH2577
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P060002/S027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2018
• Device Catalogue Number: FAS07070
• Device Lot Number: ANZH2577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 07/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1