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

Catalog Number	82086-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Flutter (1730); Cardiac Arrest (1762)
Date of Event	11/22/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the 90% stenosed left internal carotid artery.The carotid lesion was noted during a coronary angiogram, and this procedure was performed to treat both carotid and coronary arteries.The carotid artery was chosen first.A 4x30mm viatrac 14 balloon dilatation catheter (bdc) was used for pre-dilatation.An emboshield nav6 was used along with a 9x40mm xact self-expanding stent system (sess).The stent was implanted successfully.A 5x30mm viatrac 14 bdc was used for post-dilatation, and a proglide device was used to successfully complete the procedure.The patient developed atrial flutter, so dopamine was given as treatment.The patient was stable; however, the patient went into cardiac arrest.Cpr was performed, but the patient expired 30 to 45 minutes after the procedure.There were no device issues noted.In the opinion of the physician, patient death was not related to any of the devices used in the carotid procedure.No additional information was provided.
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.The reported patient effects of arrhythmia and death are listed in the xact instructions for use, as known potential patients effects associated with carotid stents and embolic protection systems.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Reportedly, in the opinion of the physician, patient death was not related to any of the devices used in the carotid procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XACT CAROTID
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9466803
• Report Number: 2024168-2019-14504
• Device Sequence Number: 16920088
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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 Catalogue Number: 82086-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMBOSHIELD NAV6; EMBOSHIELD NAV6
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Weight: 100