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

Model Number 1804225-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 03/08/2022

Event Type  Death  

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 effects of death/expired and myocardial infarction are listed in the xience skypoint everolimus eluting coronary stent systems 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.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.The xience skypoint des 2.25 x 12 referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a right posterior atrio-ventricular and right posterior descending lesions on 5/20/2021.Pre-dilatation was performed with semi-compliant balloon.A 2.25x18mm xience skypoint was deployed at 10 atmospheres without post dilatation.Then a 2.25x12mm xience skypoint was deployed at 16 atmospheres with post diliatation.No issue was noted during the procedure.On (b)(6) 2021 and (b)(6) 2022, the patient came to the hospital but no issue was noted on the patient's condition during those visits.On (b)(6) 2022, the patient died.Relation between the incident and the study is not determined.Per the physicians clinical decision the cause of death was due to acute myocardial infarction.It is unknown if an autopsy was performed.No angiography was performed.Prescribed anti-platelet drugs (clopidogrel, aspirin) were stopped being applied by the time the patient was released from hospital after percutaneous coronary interventional procedure.No additional information.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Type of Device: 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: 14160929
• MDR Text Key: 289690907
• Report Number: 2024168-2022-04243
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233005
• UDI-Public: 08717648233005
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: 1804225-18
• Device Catalogue Number: 1804225-18
• Device Lot Number: 0090341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 78 KG