MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XACT; STENT, CAROTID

Model Number	82090-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.A conclusive cause for the reported perforation of vessels, and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure.Based on the reported information, the reported death is not related to the device.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The reported patient effects of vessel perforation is listed in the xact carotid stent system information for prescribers as adverse events potentially associated with carotid stents and embolic protection systems.
Event or Problem Description
It was reported that the procedure was to treat a carotid artery.An emboshield nav6 was prepped successfully and advanced in the anatomy without issue.The filter was deployed without issue.An 8x40x136 xact stent was advanced and deployed without issue.Post dilatation was performed with 5.0 unspecified balloon and then with a 5.5 non-compliant balloon.However after the post dilatation with the second balloon was performed a small amount of blood (perforation) was observed.Balloon tamponed was performed along with applying pressure on the neck physically and no more blood was visible.However, it was noted prior to the procedure medication was given to the patient as they had very high blood pressure.Once the tamponed was performed blood pressure decreased rapidly, st elevations were noted, medication was given, but patient experienced ventricular tachycardia leading into cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed however, unsuccessful and patient expired.It was noted patient was fine post carotid procedure and per the physician's opinion the death was not related to the abbott device.No clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XACT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20612618
• Report Number: 2024168-2024-12936
• Device Sequence Number: 7327681
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: (01)08717648010262(17)261231(10)4011161
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/05/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 4011161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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: 5.5 NON-COMPLIANT BALLOON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 53 KG