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

Model Number 10607

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent fracture occurred.The target lesion was located in a very calcified artery.Following pre-dilatation with a wolverine cutting balloon, a 2.75 x 38mm synergy drug-eluting stent was advanced for treatment; however, during procedure, the stent broke.No further information is available.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10247855
• MDR Text Key: 198027565
• Report Number: 2134265-2020-08290
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840404
• UDI-Public: 08714729840404
• Combination Product (y/n): N
• Reporter Country Code: RQ
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024095364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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