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

Catalog Number 1120300-12

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately tortuous, heavily calcified left main coronary artery.Pre-dilation was performed with an nc trek balloon and a 3.0x12mm xience alpine was attempted to be advanced.It was noted the stent dislodged and snaring of the device was attempted; however, the stent separated.Only the proximal part of the stent was removed and the other part of the stent was stuck inside the calcified lesions.Another xience stent was used to successfully complete the procedure.There was no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing non-conformities 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 determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the moderately tortuous and heavily calcified lesion causing the reported stent dislodgement.A snaring device was used to remove the dislodged stent; however, the stent continued to interact with the difficult anatomy and separated during removal.The proximal portion of the stent was removed successfully; however, the distal portion of the stent remains in the patient as it was embedded in the calcified lesion.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
• MDR Report Key: 11251722
• MDR Text Key: 229360319
• Report Number: 2024168-2021-00713
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: 1120300-12
• Device Lot Number: 9042341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention