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

Model Number 10621

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

Patient Problems Cardiac Arrest (1762); Ischemia (1942)

Event Date 11/23/2021

Event Type  Death  

Event Description

It was reported that patient death occurred.The patient presented with st elevation myocardial infarction.Vascular access was obtained via the femoral artery.The 90% stenosed, 2.75 x 28mm, de novo target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.Following pre-dilation, the 2.75 x 28 synergy stent was implanted.The patient went into slow flow, no re-flow, and cardiogenic shock.Cardiopulmonary resuscitation was attempted but the patient could not be revived and died on the table.

Event Description

It was reported that patient death occurred.The patient presented with st elevation myocardial infarction.Vascular access was obtained via the femoral artery.The 90% stenosed, 2.75 x 28mm, de novo target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.Following pre-dilation, the 2.75 x 28 synergy stent was implanted.The patient went into slow flow, no re-flow, and cardiogenic shock.Cardiopulmonary resuscitation was attempted but the patient could not be revived and died on the table.It was further reported that there was no issue with stent deployment; the stent was deployed at 11 atm and the balloon inflated well.The stent was post dilated at 12 atm with a 2.75 x 9 balloon.The physician considered cause of the death to be slow flow.The patient had the history of acute coronary syndrome (acs).An autopsy was not performed.

• 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: 12910309
• MDR Text Key: 281525551
• Report Number: 2134265-2021-15131
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0027278961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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