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

Model Number H7493942828500

Device Problems Deflation Problem (1149); Activation, Positioning or Separation Problem (2906)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/28/2021

Event Type  malfunction  

Event Description

Megatron stent delivery system (sds) balloon deployed from megatron rx 5x28mm stent and would not completely deflate despite multiple attempts.Gentle retraction of the balloon despite double deflation would not remove balloon from stent.The sds balloon then detached from the sds wire, leaving the balloon occluding the vessel.Balloon able to be retrieved with a snare after patient was re-stabilized.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12120450
• MDR Text Key: 260021680
• Report Number: 12120450
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493942828500
• Device Catalogue Number: H7493942828500
• Device Lot Number: 26502747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 99