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

Model Number 10620

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

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Nausea (1970); Discomfort (2330); Diaphoresis (2452)

Event Date 02/22/2024

Event Type  Death  

Manufacturer Narrative

E1 initial reporter address: (b)(6).

Event Description

It was reported that the patient died.The patient presented with primary acute inferolateral wall myocardial infarction and cardiogenic shock post cardiopulmonary resuscitation.A 2.25 x 24 mm synergy was deployed in the obtuse marginal artery and post-dilated with a 2.50 x 10 mm non-compliant balloon.A thrombolysis in myocardial infarction (timi) flow of 3 was achieved and the procedure was completed.7 hours later, the patient experienced high blood pressure, discomfort, sweating, nausea and angiogram revealed slow flow.Flow was unable to be restored and the patient went into cardiac arrest.Despite provided medication and cardiopulmonary resuscitation (cpr), the patient died.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18852798
• MDR Text Key: 337067270
• Report Number: 2124215-2024-13944
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0029181383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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 Race: Asian