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

Model Number 1804350-38

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

Patient Problems Arrhythmia (1721); Bradycardia (1751)

Event Date 04/24/2023

Event Type  Injury  

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; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect of arrhythmia is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat mildly calcified, 95% stenosed lesions in the left anterior descending (lad), right coronary (rca) and diagonal (left coronary) arteries.On (b)(6) 2023, the patient had 7 xience skypoint drug eluting stents (des) implanted without issue.A 4.5x33mm and 4.5x18mm stents were placed in the rca.A 3.0x38mm, 3.5x38mm and 3.5x8mm stents were placed in the lad.A 2.5x18mm and 2.5x8mm stents were placed in the diagonal artery.On (b)(6)2023, the patient presented to a different physician experiencing constant arrhythmias throughout the day and bradycardia with heart rates of 32-35 beats per minute (bpm).The patient was asymptomatic prior to his procedure on 3/24/2023.Additional treatment has not yet been provided.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.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: 17035767
• MDR Text Key: 316287462
• Report Number: 2024168-2023-05698
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233449
• UDI-Public: 08717648233449
• 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: 05/31/2023

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
• Device Operator: Health Professional
• Device Model Number: 1804350-38
• Device Catalogue Number: 1804350-38
• Device Lot Number: 2072641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Male