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

Model Number 1804300-28

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problems Angina (1710); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Respiratory Failure (2484); Thrombosis/Thrombus (4440)

Event Date 01/05/2022

Event Type  Death  

Manufacturer Narrative

The clip remains in patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Na.

Event Description

It was reported that on (b)(6) 2022, a procedure was performed to treat the bifurcation of the left anterior descending (lad) artery. Three xience skypoint's were deployed without issues. An additional skypoint was attempted to be inserted, but the physician noticed the stent became damage while pushing through the tuohy. Therefore, the stent was removed and a balloon was inserted in an attempt to pass through the most proximal implanted stent. However, the balloon was unable to pass through the stent and after roughly 30 minutes, it was observed the implanted stent had become completely occluded. Clots were then observed at the occluded stent and in the left main. It was noted no clotting occurred near the other two implanted stents. Additional heparin was then administered. Aspiration was performed and the clot was successfully removed. However, the st elevation increased and the patient started to have chest pains. The patient then became unresponsive and chest compressions were performed. The patient was intubated and left the operating room on a ventilator. On (b)(6) 2022, the patient passed away. 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: 13344453
• MDR Text Key: 284832070
• Report Number: 2024168-2022-00828
• Device Sequence Number: 1
• Product Code: NIQ
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1804300-28
• Device Catalogue Number: 1804300-28
• Device Lot Number: 1032241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/25/2022 Patient Sequence Number: 1

Treatment

IMPLANTED XIENCE SKYPOINT (X2)