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

Catalog Number 1120250-23

Device Problems Break (1069); Material Separation (1562); Packaging Problem (3007)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the right coronary artery (rca).The 2.5x23 mm xience alpine stent was noted to be broken upon unpackaging.The dispenser hoop was also noted to be kinked.There was no device use or patient involvement.Another xience alpine sds was used to complete the procedure.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned for analysis.The reported packaging problem (kinked coil) was not confirmed.The reported material separation (shaft) 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 other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported packaging problem (kinked coil) and material separation (shaft).There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code updated from 1069 to 1562.

Event Description

It was reported that the procedure was to treat the right coronary artery (rca).The 2.5x23 mm xience alpine stent was noted to be broken upon unpackaging.The dispenser hoop was also noted to be kinked.There was no device use or patient involvement.Another xience alpine sds was used to complete the procedure.There was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, it was reported the stent was not in two pieces but the hypotube was separated.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 18136417
• MDR Text Key: 328109784
• Report Number: 2024168-2023-12660
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UY
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1120250-23
• Device Lot Number: 3051741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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