MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Model Number 9554

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Ventricular Fibrillation (2130); Sudden Cardiac Death (2510); Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2020

Event Type  Death  

Event Description

It was reported that balloon detachment and patient death occurred.The patient presented with acute infarction.The 80% stenosed target lesion was on the mildly calcified and mildly tortuous anterior descendent and another lesion was located in the right coronary artery.The descendent lesion was predilated with a balloon and the 38 x 2.75 promus premier drug eluting stent deployed.When the stent balloon was deflated and an attempt was made to remove it from the stent, the balloon detached and remained inside the patient.The physician tried to use a guidewire to remove the balloon without success.Minutes later the patient went into cardiac arrest with ventricular fibrillation and after three rounds of resuscitation maneuvers, the patient was declared dead.The physician considered the balloon left inside the patient, along with the patient being unstable, contributed to the cardiac arrest and death.No autopsy was performed.

Event Description

It was reported that balloon detachment and patient death occurred.The patient presented with acute infarction.The 80% stenosed target lesion was on the mildly calcified and mildly tortuous anterior descendent and another lesion was located in the right coronary artery.The descendent lesion was predilated with a balloon and the 38 x 2.75 promus premier drug eluting stent deployed.When the stent balloon was deflated and an attempt was made to remove it from the stent, the balloon detached and remained inside the patient.The physician tried to use a guidewire to remove the balloon without success.Minutes later the patient went into cardiac arrest with ventricular fibrillation and after three rounds of resuscitation maneuvers, the patient was declared dead.The physician considered the balloon left inside the patient, along with the patient being unstable, contributed to the cardiac arrest and death.It was further reported that the physician became aware of the problem when the balloon did not fully inflate.Before trying to pull the system out, the balloon was fully deflated approximately 5-8 seconds.Upon removal, the balloon was caught in the deployed stent and was left in the area where the stent was deployed.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10606346
• MDR Text Key: 209252861
• Report Number: 2134265-2020-12823
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0024987635
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 65