MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070350-48

Device Problems Leak/Splash (1354); Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a moderately calcified left anterior descending artery that is 80% stenosed.The 3.5x48mm xience xpedition stent delivery system was advancing through an unspecified guide catheter; however, could not advance further as resistance was noted with the unspecified guide catheter.Once withdrawn it was noted the struts were flared.Another xience xpedition was used to successfully complete the procedure.There were no adverse patient effects reported and no clinically significant delay reported.Per device analysis the outer member was torn 1.6cm distal from the guide wire lumen for a length of 3mm.The balloon did not inflate, and fluid was observed coming out from the tear in noted the outer member.No additional information was provided.

Manufacturer Narrative

A visual, dimensional, and functional inspection were performed on the returned device.The reported material deformation was confirmed.The reported difficult to advance could not be tested as it was based on operational context.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties, the noted leak / splash, and the noted torn material.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XIENCE XPEDITION 48 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: 14847043
• MDR Text Key: 295797120
• Report Number: 2024168-2022-06990
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2022

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 Expiration Date: 04/19/2024
• Device Catalogue Number: 1070350-48
• Device Lot Number: 1041241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 105 KG