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.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• 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
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• 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

• Device Expiration Date: 12/17/2021
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0024987635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/30/2020 Patient Sequence Number: 1