MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT

Model Number H7493942832350

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Event Description

It was reported that deflation and removal difficulty occurred. A percutaneous coronary intervention (pci) was performed on a moderately calcified right coronary artery (rca). A 3. 50 x 32mm synergy megatron was advanced to the lesion, the balloon was inflated one time at 12 atmospheres for 8 to 10 seconds, and was deployed in the rca. However, the balloon would not deflate. A double negative was performed using a 3-way but it did not do much and the device had to be removed with a lot of effort. The procedure was completed with this device. No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 12511092
• MDR Text Key: 272660215
• Report Number: 2134265-2021-11929
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/02/2021
• Device Model Number: H7493942832350
• Device Lot Number: 0026505660
• 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: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial