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

Catalog Number	FAF06050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2016
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 distal portion of the stent sheath allegedly broke.No further procedural details were provided at the time of report.There was no reported impact or consequence to the patient.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/ inspection: the delivery system was returned.The safety clip was missing upon receipt of the sample.The tuohy borst adapter was loose and the two-way stop cock was opened.The stent graft was found to be released and was not returned with the delivery system.A portion of the distal end of the inner catheter including the atraumatic tip was torn off from the delivery system and measured 51mm in length.The inner catheter appears to be twisted and kinked on the detached portion.A bend was noted in the returned portion of the outer catheter 16.8cm from the strain relief.The outer catheter was noted to exhibit stretching in this location.No other anomalies were noted to the returned delivery system.Functional/performance evaluation: no functional testing was performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for detachment, as a portion of the inner catheter including the atraumatic tip was returned separated from the rest of the delivery system.Per the reported event details, there was a stent previously placed adjoining the intended location.Therefore, it is possible the already implanted stent contributed to the detachment.However, the definitive root cause in unknown.Labeling review: the current ifu (instructions for use) states: 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.The distal end of the flared configuration devices are approximately 4 mm larger in diameter than the body section.Precautions: faulty placement techniques may lead to failure in stent graft deployment.Do not kink the delivery system.The delivery system can function only after the red safety clip has been pulled off and the tuohy-borst valve is loosened.This should not be done until the stent graft is positioned across the lesion and is ready to be deployed.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.Potential complications and adverse events: 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).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 distal end/nose cone of the stent delivery system detached from the catheter during deployment of the stent graft in the left axillary vein.It was further reported that the detached tip was retrieved with a snare device.Reportedly, the procedure was successfully completed with directed catheter thrombolysis, stent deployment, and post intervention venography.There was no reported impact or consequence to the patient.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• MDR Report Key: 5533680
• Report Number: 2020394-2016-00306
• Device Sequence Number: 601598
• Product Code: MIH
• UDI-Device Identifier: 04049519008752
• UDI-Public: (01)04049519008752(17)180319(10)ANZC2189
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060002/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2016

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: 03/19/2018
• Device Catalogue Number: FAF06050
• Device Lot Number: ANZC2189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2016
• Supplement Report FDA Received Date: 05/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR