MAUDE Adverse Event Report: ABBOTT VASCULAR CORONARY DRUG-ELUTING STENT

Model Number XIENCE SIERRA 3.5MM X 33MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2020

Event Type  malfunction  

Event Description

Xience sierra stent was to be utilized for pci of rca.Stent was prepped in the usual fashion and device was placed into the pt in normal fashion.After balloon inflation and attempted stent deployment it was determined that the stent was not present in the artery as expected.Upon further investigation, the stent was found having never been inserted into the pt.It was apparent that the stent had been dislodged from the delivery balloon and was found on the sterile procedure table.Fda safety report id# (b)(4).

• Brand Name: CORONARY DRUG-ELUTING STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 9706349
• MDR Text Key: 179424223
• Report Number: MW5092968
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: XIENCE SIERRA 3.5MM X 33MM
• Device Catalogue Number: 1550350-33
• Device Lot Number: 9102141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 112