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

Catalog Number 1120350-28

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that when removing the xience alpine drug eluting stent system (des) from the package, it was noted the device label (3.50x33mm)(lot 3060641) did not match the packaging labeled size, 3.50x28mm (lot 3081041).There was no clinically significant delay in the procedure and no patient involvement.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

C8 - #1 event abated after use stopped: change to doesn't apply c9 - #1 event reappeared after reintro: change to doesn't apply the device was returned for analysis.The reported labeling issue was not confirmed.A corrective and preventive actions (capa) review was performed and revealed no indication of a product quality issue.The investigation was unable to determine a conclusive cause for the reported labeling problem as the device was returned and the labeling on chipboard box, foil pouch, inner pouch and device all matched.There was no discrepancy on the labeling of any of the components.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: 18641863
• MDR Text Key: 334564593
• Report Number: 2024168-2024-01406
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648205835
• UDI-Public: (01)08717648205835(17)260731(10)3081041
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1120350-28
• Device Lot Number: 3081041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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