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

Catalog Number	1804250-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a left anterior descending artery (lad) lesion.A 2.5x33mm xience skypoint stent delivery system (sds) was implanted mid-distal and then a 3.0x28mm xience skypoint was implanted proximal-mid with a slight overlap.The stents were post-dilated.There was significant tissue protrusion [prolpase] at the proximal portion of the 2.5x33mm xience skypoint stent just distal to the overlap.It was stented over with 2.5x15mm xience skypoint stent.The procedure was finished at which point the patient started having chest pain.The patient was re-accessed and it was noted that the 2.5x15mm stent thrombosed at the point of tissue protrusion.Stents were post-dilated again.Additionally, proximal calcium at the ostial lad was treated with shockwave and then stented over with a 3.5x18mm xience skypoint stent.Procedure was finished.Patient was removed off the table and started having chest pains again and went into ventricular fibrillation, which was treated with defibrillation.Patient was then transferred to the intensive care unit where he had two more episodes of chest pain and defibrillation.Patient was ultimately successfully discharged.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional 2.50 x 15 skypoint device referenced in b5 is filed under a separate medwatch report number.
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.The reported patient effect(s) of prolapse is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.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.

• 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: 18328676
• Report Number: 2024168-2023-14020
• Device Sequence Number: 15293401
• Product Code: NIQ
• UDI-Device Identifier: 08717648233111
• UDI-Public: 08717648233111
• 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): 01/18/2024

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 Expiration Date: 03/07/2026
• Device Catalogue Number: 1804250-33
• Device Lot Number: 3032041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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: 3.0X28MM XIENCE SKYPOINT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 73 KG