MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	82092-01
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The emboshield nav6 device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified vessel in the left carotid artery.The emboshield nav 6 embolic protection system (eps) was used and the barewire was switched to the 315mm.The filter was deployed.No pre-dilatation was performed.The xact carotid stent system was attempted to be advanced on the barewire but there was resistance and it only made it into the sheath.It was attempted to remove the delivery system but it could not be removed even with push and pull action.Ultimately there was no way to retrieve the filter, so the filter was removed open and together with the xact stent, that was not deployed, and was pulled as one unit.Another eps, xact stent and barewire were used to complete the procedure.There was no adverse patient effect.There was a delay in the procedure as all the devices had to be taken from a different department but there was no harm to the patient.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned ses, and the reported difficulty to advance and remove were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported difficulty to advance and remove appear to be related to case circumstances of the procedure.Based on the reported information, there was no pre-dilation of the heavily calcified vessel.It is likely that difficulty to advance was due to the heavy calcification.Manipulation against resistance likely caused damage to the inner lumen of the xact device and barewire freezing in place resulting in the difficulty to remove and partially deploying the tip of the stent.The noted bends and coil damage on the barewire likely occurred post procedure or during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XACT CAROTID STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13620414
• Report Number: 2024168-2022-02056
• Device Sequence Number: 5817842
• Product Code: NIM
• UDI-Device Identifier: 08717648010286
• UDI-Public: 08717648010286
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 04/30/2024
• Device Model Number: 82092-01
• Device Catalogue Number: 82092-01
• Device Lot Number: 1051761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BAREWIRE 315; NAV6 FILTER
• Patient Age: 82 YR
• Patient Sex: Male