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

Model Number 10632

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 01/25/2022

Event Type  Death  

Manufacturer Narrative

Initial reporter first name: (b)(6).

Event Description

It was reported that the patient died.The patient presented in critical condition with myocardial infarction.An 85% target lesion was located in the right coronary artery (rca) and a 90% stenosed target lesions was located in the left anterior descending artery (lad).After the rca was treated using a non-boston scientific (bsc) pre-dilation balloon followed by the implanting of a non-bsc stent, pre-dilatation of the lad was performed using a 2.0x20mm non-bsc balloon.At that time, slow flow occurred and the patient went into cardiac arrest followed by hypotension.Intra coronary adrenaline was given and cardiopulmonary resuscitation was performed on the patient.Afterwards, a 3.00x48mm synergy drug-eluting stent was deployed in the lad.The patient again went into cardiac arrest and expired on the table.The official cause of death was cardiac arrest followed by hypotension.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: 13515756
• MDR Text Key: 285482453
• Report Number: 2134265-2022-01002
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BG
• 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
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0027825737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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