MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE XPEDITION; CORONARY DRUG-ELUTING STENT

Model Number 1070275-23

Device Problems Material Separation (1562); Failure to Advance (2524)

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

Event Date 03/13/2024

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 the procedure was to treat a de novo lesion in the circumflex (cx) artery with 90% stenosis, heavy calcification and heavy tortuosity.The shaft of the 2.75x23mm xience xpedition stent delivery system (sds) broke into two pieces due to the anatomy and failed to cross the lesion.The sds was simply withdrawn.Another non-abbott device was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported failure to advance could not be tested as it was based on operational context.The reported material separation was confirmed.A review of the production records and the corrective and preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the stent delivery system (sds) failed to advance due to interaction with the patient¿s heavily calcified, heavily tortuous, and 90% stenosed lesion.Manipulation of the sds, during its interaction with the anatomy, may have contributed to the reported shaft separation.Analysis of the returned device noted the fracture face of the separation to be oval and jagged.This type of damage is consistent with a separation at a kink.It is likely that the guide wire kinked during the procedure, then subsequent movement of the device resulted in the separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Additional information: d4 - model # added.Corrections: d1 - brand name updated.D2a - common device name updated.D3 - name updated.D3 - address, city, postal code updated.

• Brand Name: XIENCE XPEDITION
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19021049
• MDR Text Key: 339131199
• Report Number: 2024168-2024-04071
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648157806
• UDI-Public: (01)08717648157806(17)260129(10)3020841
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• 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: 07/26/2024

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 Model Number: 1070275-23
• Device Catalogue Number: 1070275-23
• Device Lot Number: 3020841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 07/23/2024
• Supplement Dates FDA Received: 07/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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