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

Model Number	82091-01
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Air Embolism (1697); Transient Ischemic Attack (2109)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 incidents from this lot.The reported patient effects of embolism and tia- transient ischemic attack is listed in the x-act carotid stent system instructions for use as adverse events potentially associated with carotid stents and embolic protection systems.The investigation determined the reported difficult to advance appears to be related to circumstances of the procedure as it is likely that resistance was met with the calcified anatomy resulting in the reported difficulty to advance.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat the left internal carotid artery.An emboshield nav 6 embolic protection system was first deployed without reported issue.The xact carotid stent system was attempted but could not cross the lesion due to the calcification.It was taken out and pre-dilatation was performed with a viatrac balloon dilatation catheter (bdc) without reported issue.The same xact stent delivery system was advanced and was deployed.The status of the stent is known to be patent.At this point, angiogram was performed and when the contrast was injected, air bubbles were seen in the vessel.The patient suffered a transient ischemic attack (tia) and could not speak and had decreased strength with her right hand.The emboshield nav6 filter was removed.After approximately 5-10 minutes, the symptoms resolved.No treatment was reported.A computed tomography (ct) scan was performed after leaving the cath lab.The patient had hospitalization but it was originally planned.The next day the patient's symptoms were back to baseline.There was no significant delay in the procedure.No additional information was provided.

• 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: 12828804
• Report Number: 2024168-2021-10469
• Device Sequence Number: 4419338
• Product Code: NIM
• UDI-Device Identifier: 08717648010279
• UDI-Public: 08717648010279
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 82091-01
• Device Catalogue Number: 82091-01
• Device Lot Number: 9062061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2019
• 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: EMBOSHIELD EMBOLIC PROTECTION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 52 KG