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

Catalog Number UNK XIENCE

Device Problem Break (1069)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.An unknown xience stent delivery system (sds) had a fractured wire [delivery catheter].There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

D4: the udi is unknown because the part/lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was not returned for analysis.A review of the electronic lot history record (elhr) and lot level similar incident search for this product were not performed because the part and lot numbers were not reported and the product was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported shaft break.It is possible that the device was inadvertently mishandled during advancement, as no failures were reported during preparation, resulting in the reported break.Without having the device to examine and limited information provided, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE EVEROLIMUS ELUTING CORONARY STENT 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: 18368639
• MDR Text Key: 331296509
• Report Number: 2024168-2023-14282
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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