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); High Blood Pressure/ Hypertension (1908); Discomfort (2330); Diaphoresis (2452)

Event Date 10/22/2023

Event Type  Death  

Event Description

It was reported that slow flow occurred, and the patient died.The patient presented in medical emergency with triple vessel disease.A 2.75 x 48 mm synergy was implanted in the ostium to mid left anterior descending artery (lad).A 3.50 x 32 mm synergy was implanted in the ostia to mid left circumflex (lcx).The stents were post-dilated via the kissing balloon technique and a thrombolysis in myocardial infarction (timi) flow of 3 was achieved.The procedure was completed.Five hours later, the patient experienced discomfort, sweating and high blood pressure and was transferred to the cath lab.An angiogram was completed and slow flow was noted.Medical treatment was provided, but flow did not improve.The patient suddenly went into cardiac arrest and could not be revived despite treatment provided.

• 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: 18088264
• MDR Text Key: 327585241
• Report Number: 2124215-2023-62587
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0030655581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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