MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1804325-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/30/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The unique device identifier (udi) is unknown because the part number and lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat an unknown lesion in the left anterior descending (lad) artery.A 2.5 trek balloon dilatation catheter (bdc) and a non-abbott intravascular lithotripsy (ivl) catheter were used to prepare the vessel, after which a 3.5x23mm skypoint drug eluting stent (des) was implanted.Via imaging, the distal end looked hazy.Thrombosis was noted.A 3.0 nc trek bdc was used.Cariopulmonary resuscitation was started but was unsuccessful and the patient expired.No additional information was provided.
Event or Problem Description
Subsequent to the previously filed report, it was reported that the lesion was 90% stenosed prior to the procedure.No additional information was provided.
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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effects of thrombosis and death are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.B5 - describe event or problem: updated d4 - catalog #.Lot #, udi were updated from "unk xience skypoint/ unknown/ ni" to: 1804325-23 / 2021141 / (b)(4).

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16569563
• Report Number: 2024168-2023-02814
• Device Sequence Number: 20368051
• Product Code: NIQ
• UDI-Device Identifier: 08717648233333
• UDI-Public: 08717648233333
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/02/2023

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 Expiration Date: 02/15/2024
• Device Model Number: 1804325-23
• Device Catalogue Number: 1804325-23
• Device Lot Number: 2021141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/18/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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: 2.5 TREK BDC; 3.0 NC TREK BDC; NON-ABBOTT INTRAVASCULAR LITHOTRIPSY (IVL) CATHETE
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown