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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/11/2020

Event Type  Death  

Event Description

It was reported that the patient died.The target lesion was located in the left anterior descending artery (lad).After the lesion were crossed with a non-bsc guidewire and pre-dilated with a non-bsc balloon catheter, the two 2.25x16 synergy drug-eluting stent (des) were placed in the lad and a 2.25x12 synergy des were placed in the mid to distal lad.The physician moved to work in the circumflex, the wire was able to get down but they struggled with the balloon catheter.After the balloon passed, a 2.25x8 synergy des was advanced but it failed to cross the lesion.A 2.0x8 non-bsc stent was also unable to be unsuccessful placed, so the procedure was completed without placing a stent in the circumflex.However, it was noted that the patient crashed and was unable to be revived.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10943451
• MDR Text Key: 219477210
• Report Number: 2134265-2020-16600
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2020
• 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): Death
• Patient Age: 72 YR