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

Catalog Number 1804300-18

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

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.Reportedly, the 3.0x18mm xience skypoint stent was implanted on(b)(6) 2024; however, post procedure it was noted that the stent expired on (b)(6) 2024.It should be noted that the xience skypoint instructions for use (ifu) states: do not use after the ¿use by¿ date.The expiration date of the product is important for sterility, efficacy, and performance of the device.In this case there was no reported patient adverse events reported.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use as it is likely that the device was inadvertently used after the use by date.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6- medical device problem code 2017 clarifier: use after expiration.

Event Description

It was reported that the procedure was treat a lesion in the distal circumflex artery.The 3.0x18mm xience skypoint stent was implanted on (b)(6) 2024; however, post procedure it was noted that the stent expired on (b)(6) 2024.There were no adverse patient effects and no clinically significant delay in the procedure.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: 19015805
• MDR Text Key: 339082708
• Report Number: 2024168-2024-04024
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233241
• UDI-Public: (01)08717648233241(17)240214(10)2020942
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2024
• Device Catalogue Number: 1804300-18
• Device Lot Number: 2020942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2022
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 103 KG