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

Model Number 1804500-28

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

Patient Problems Ventricular Fibrillation (2130); Perforation of Vessels (2135)

Event Date 02/03/2023

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, perforation, and ventricular fibrillation/arrhythmia are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use (ifu) 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 subsequent 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.

Event Description

It was reported that the patient presented in poor condition with an ejection fraction of 10% (normal 50-65%), friable vessels, chest pain and a history of coronary heart disease.During the procedure, the 5.00x28mm xience skypoint stent was advanced to the lesion in the saphenous vein graft (svg), and deployed at 12 atmospheres; after which, a large perforation was noted, due to the friable vessel.Three non-abbott covered stents were implanted to successfully seal the perforation; however, the patient went into ventricular fibrillation.Cardiopulmonary resuscitation was performed and the automatic implantable cardioverter defibrillator (aicd) defibrillated the patient a couple of times.Additionally, the patient was defibrillated multiple times with an external defibrillator, but could not be resuscitated and died.In the physician's opinion, the xience stent did not cause the perforation.The perforation was due to the patient having a friable vessel.The xience stent had no device issues.No additional information was provided.

• 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: 16436961
• MDR Text Key: 310165078
• Report Number: 2024168-2023-01892
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233661
• UDI-Public: 08717648233661
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: 1804500-28
• Device Catalogue Number: 1804500-28
• Device Lot Number: 2030441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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): Death
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 86 KG