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

Catalog Number 1011709-33

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 07/31/2020

Event Type  Injury  

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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Interaction and/or manipulation of the device ultimately resulted in the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified de novo mid left anterior descending artery that was 95% stenosed.A 3x33mm xience prime stent was advanced but failed to cross due to anatomy.When pulling back resistance was met with anatomy, and the stent implant dislodged.Unable to retrieve the dislodged stent, another stent was deployed to embed the dislodged stent to the vessel wall.Patient remained stable.There was no clinically significant delay.No additional information was provided.

• Brand Name: XIENCE PRIME
• 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: 10455268
• MDR Text Key: 204406577
• Report Number: 2024168-2020-07124
• Device Sequence Number: 1
• Product Code: NIQ
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 1011709-33
• Device Lot Number: 9092441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention