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

Model Number 1804300-15

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the xience skypoint stent delivery system box was labeled 3.0x15mm (part#1804300-15, lot#1060941) but when the box was opened, the pouch was labeled 3.0x28mm (on the pouch: part# 1804300-28, lot#1032241); therefore, the device was not used.There was no evidence of tampering with the box and the pouch was sealed.A new 3.0x15mm skypoint was used.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported labeling problem was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 13389575
• MDR Text Key: 289292370
• Report Number: 2024168-2022-00984
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: 08717648233234
• 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,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: 1804300-15
• Device Catalogue Number: 1804300-15
• Device Lot Number: 1060941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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