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

Catalog Number 1804400-12

Device Problem Defective Device (2588)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that prior to use the 4.0x12mm xience skypoint stent appeared to be larger in size than usual and was not used.Another xience stent was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported defective device was not confirmed.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.A conclusive cause for the reported defective device could not be determined; however, potential factors that could contribute to a defective device include, but are not limited to, poor visibility/radiopacity, incorrect size selection, inaccurate stent placement or stent uniformity.Based on the information provided and analysis of the returned device, a definitive cause for the reported defective device cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3 - device returning status updated from unknown to returned.

• 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: 19098419
• MDR Text Key: 340102667
• Report Number: 2024168-2024-04648
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233463
• UDI-Public: (01)08717648233463(17)260904(10)3091241
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804400-12
• Device Lot Number: 3091241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2023
• 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