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

Catalog Number 1120400-23

Device Problem Unsealed Device Packaging (1444)

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

Event Date 11/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the upon opening the box of a 4x23mm xience alpine drug eluting stent system (dess), it was noted that the foil pouch was opened, and the inner sterile barrier had been breached.The device was not used for the procedure.There was no patient involvement and no clinically significant delay in the procedure.A new stent was prepared and used to successful complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported unsealed device packaging was not confirmed.The stent delivery system (sds) was returned inside the sealed tyvek pouch, opened foil pouch and in the chipboard box.The top portion of the foil pouch was torn.The top vendor seal was still intact.There was no other damage noted to the returned foil pouch.There was no seal issue as reported.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported unsealed device packaging as the issue could not be confirmed during return device evaluation.The bottom foil pouch seal was complete and undamaged suggesting the device was originally packaged and sealed securely at the time of manufacture.The inner plastic pouch was returned sealed.Based on the reported information and analysis of the returned device, it is possible that the foil pouch was inadvertently opened and placed back into the packaging box; however, this could not be confirmed and a conclusive cause could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12953835
• MDR Text Key: 281866975
• Report Number: 2024168-2021-11190
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: MY
• 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,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Catalogue Number: 1120400-23
• Device Lot Number: 9121841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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