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

Catalog Number	1804275-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was a reported that the 2.75x23mm xience skypoint stent was implanted in the proximal left anterior descending (plad) artery approximately 1 year ago.On (b)(6) 2023 the patient did not receive dual antiplatelet therapy (dapt) medication and was re-hospitalized on (b)(6) 2023 with chest pain, thrombus and a myocardial infarction.The lad was noted to have re-stenosed.A non-abbott device was used to de-clot the lesion followed by implantation of a 3.25x15mm xience skypoint stent to treat the restenosis.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
C4, d6: implant date estimated.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The reported patient effects of angina, myocardial infarction and thrombosis are listed in the xience skypoint everolimus eluting coronary stent system electronic instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the reported treatments appear 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.

• 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: 17545985
• Report Number: 2024168-2023-08763
• Device Sequence Number: 6535113
• Product Code: NIQ
• UDI-Device Identifier: 08717648233173
• UDI-Public: 08717648233173
• 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: 2022
• 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): 08/14/2023

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 Catalogue Number: 1804275-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG