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

Model Number 10600

Device Problem Failure to Advance (2524)

Patient Problems Death (1802); Obstruction/Occlusion (2422)

Event Date 08/21/2020

Event Type  Death  

Event Description

It was reported that the patient died.The target lesion was located in the left anterior descending artery.Following pre-dilatation with a 3.00x20 apex balloon, a 3.00 x 8 synergy drug-eluting stent was advanced but failed to cross the lesion.It was noted that the lesion went down and the patient went to the operating room where they subsequently died.

• 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: 10544450
• MDR Text Key: 207280176
• Report Number: 2134265-2020-11969
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: 08714729839996
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0023942533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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
• Patient Outcome(s): Death