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

Catalog Number 1120225-15

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: estimated date.Exemption number e2019001.(b)(4).The device was not returned for analysis.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.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use states: do not use after the use by date.The investigation determined the reported difficulties appear to be related to user error as the device was used past the expiration date.

Event Description

It was reported that a consumption report was received regarding a 2.25x15mm xience alpine stent that expired on 29-aug-2019.After consultation with the account, the hospital staff refused to give a statement when the implantation took place.Therefore, it is possible that the stent was implanted after the expiration date.The implantation was successful and the patient is doing well.No issues occurred during or after the procedure.No additional information was provided.

• Brand Name: XIENCE ALPINE
• 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: 9419593
• MDR Text Key: 177772081
• Report Number: 2024168-2019-14213
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2019
• Device Catalogue Number: 1120225-15
• Device Lot Number: 6082441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2016
• 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