MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10602

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent fracture occurred.The severely stenosed target lesion was located in a mildly tortuous and moderately calcified circumflex artery as well as the left main artery.A 4.00 x 16 synergy stent was selected for use.During percutaneous coronary intervention, there were two balloons that were down and the stent expanded well.As the physician was removing the device from the circumflex artery, it was noted that the distal segment of the device broke probably about 60 cm from the distal end, and the broken piece remained inside the patient.Subsequently, the physician was able to take a 2.5 x 15 balloon past the synergy delivery device, trapped it and pulled the piece that was broken off back into the guide catheter and removed the whole system to retrieve the broken part.Furthermore, the broken part of the synergy was removed, the case was able to continue afterwards.The procedure was completed with the same device.No patient complications were reported.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8374886
• MDR Text Key: 137291654
• Report Number: 2134265-2019-01402
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 22618540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR