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); No Consequences Or Impact To Patient (2199); 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 (lad) artery.Following pre-dilatation with a 3.00 x 12 apex balloon, a 3.00 x 8mm synergy ii drug-eluting stent was advanced but failed to cross the lesion and the lad went down.The patient was sent to operating room for surgery but before they could get the patient on bypass, he expired.

Manufacturer Narrative

This event is a duplicate and has already been reported under emdr 2134265-2020-11969.

Event Description

It was reported that the patient died.The target lesion was located in the left anterior descending (lad) artery.Following pre-dilatation with a 3.00 x 12 apex balloon, a 3.00 x 8mm synergy ii drug-eluting stent was advanced but failed to cross the lesion and the lad went down.The patient was sent to operating room for surgery but before they could get the patient on bypass, he expired.

• 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
• MDR Report Key: 10544478
• MDR Text Key: 207280177
• Report Number: 2134265-2020-11970
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: 08714729839996
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

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: 01/01/2022
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0024977244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death