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

Model Number 1804325-18

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

Patient Problems Angina (1710); Dyspnea (1816); Diaphoresis (2452); Thrombosis/Thrombus (4440)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effects of angina, dyspnea and thrombosis are listed in the xience skypoint, everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent unexpected medical intervention (additional therapy/non-surgical treatment) appears 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 on (b)(6) 2021, a percutaneous coronary intervention was performed on the mid left anterior descending (lad) coronary artery lesion.Angiomax was provided pre-procedure.Following, a 3.25x18mm xience skypoint stent was implanted without issues reported.The procedure was completed and the patient was in recovery.600 mg of plavix had been provided per protocol.Approximately 30 minutes later, the patient had become diaphoretic, dyspneic, and had angina.Imaging was performed and the xience skypoint stent had occluded with thrombus.As treatment , three additional xience skypoint stents were implanted.The event resolved and did not require prolonged hospitalization.No additional information as provided regarding this issue.

• 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: 12836052
• MDR Text Key: 280956039
• Report Number: 2024168-2021-10551
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233326
• UDI-Public: 08717648233326
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: 1804325-18
• Device Catalogue Number: 1804325-18
• Device Lot Number: 1051441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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): Required Intervention