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

Catalog Number	1804250-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.D4- the udi number is not known as the catalogue number was not provided.
Event or Problem Description
It was reported that the patient had a carotid surgery on (b)(6) 2023, which a 7-10/40 acculink stent and a 9tx40x136 xact stent were implanted with not reported issue.On (b)(6) 2023, the patient presented with a stemi and a 2.5x8mm xience skypoint was implanted and the procedure was completed.An occlusion in the left main was observed via angiogram.It was noted that the patient had to be intubated post procedure and patient expired on (b)(6) 2023.No additional information was provided.
Event or Problem Description
Subsequently, after the initial report was filed it was reported that the patient had a carotid surgery on (b)(6) 2023, which a 7-10/40 acculink stent and a 9tx40x136 xact stent were implanted with no reported issue.On (b)(6) 2023, the patient presented with a stemi and an occlusion in the left main was observed.A 2.5x8mm xience skypoint was implanted and the procedure was completed.It was noted that the patient had to be intubated post procedure and patient expired on (b)(6) 2023.In the physician¿s opinion, the xience did not cause or contribute to the patient's death.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 effect(s), and the relationship to the product, if any, cannot be determined.In the physician¿s opinion, the xience skypoint did not cause or contribute to the patient's death.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.B2 - outcomes attributed to ae updated from "death" to "na".B5 - describe event or problem: revised.D4 - catalog # updated from "unk xience skypoint" to 1804250-08.D4 - lot # updated from "unknown" to 107094a.H6 - health effect - clinical/impact codes (b)(4) were added.

• 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: 18249924
• Report Number: 2024168-2023-13328
• Device Sequence Number: 6644538
• Product Code: NIQ
• UDI-Device Identifier: 08717648233050
• UDI-Public: 08717648233050
• Combination Product (Y/N): Y
• 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): 01/08/2024

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: 07/21/2024
• Device Catalogue Number: 1804250-08
• Device Lot Number: 107094A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: Death
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic