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

Model Number 10619

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

Patient Problem Ischemia (1942)

Event Date 03/08/2022

Event Type  Death  

Event Description

It was reported that a patient death occurred.The first target lesion was located in the right coronary artery (rca) and the second lesion in the left main coronary artery (lmca).A 2.50 x 38 synergy drug eluting stent and a 2.75 x 20 synergy drug eluting stent were deployed to treat the lesions.Following the deployments, a proximal optimization technique (pot) was performed in the left main (lm).Afterward, while re-crossing, the left circumflex (lcx) occluded and the patient experienced hypotension and bradycardia.Despite administration of medications and support with intra aortic balloon pump (iabp), the patient was unable to revive, ultimately resulting in the patient passing away.It was further reported that the patient presented with triple vessel disease with left main disease.The left circumflex became occluded while re-crossing the wire and no flow occurred.The physician assessment was that there was no relationship to the patient death and the devices used.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13945295
• MDR Text Key: 288165929
• Report Number: 2134265-2022-03615
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2023
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0026734622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: Asian