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

Catalog Number 1120300-33

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

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 other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported missing components (stent).Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that before use and while opening the packaging from a 3.0x33 xience alpine stent delivery system, it was noted that the chipboard box was opened and the stent implant was missing.The device was not used and there was no patient involvement.There were no adverse patient effects and no clinically significant delay in 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9986624
• MDR Text Key: 188534676
• Report Number: 2024168-2020-03829
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2020

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: 10/17/2021
• Device Catalogue Number: 1120300-33
• Device Lot Number: 8092461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1