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

Model Number 10623

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

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Tachycardia (2095); Insufficient Information (4580)

Event Date 08/17/2021

Event Type  Death  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that a patient death occurred.The patient presented to the hospital with chest pain and anxiety for the last three days.An ecg was performed and confirmed acute inferior wall st elevation myocardial infarction (iwstemi).The patient underwent a coronary angiogram (cag), which revealed triple vessel disease.Vascular access was obtained via the femoral artery.A coronary angioplasty was performed on a 3.00mm x 34mm, moderately tortuous, and mildly calcified right coronary artery (rca).A 3.00 x 38 synergy drug eluting stent was advanced to the target lesion, and deployed.Significant resistance was encountered while advancing.The procedure was completed and the patient was stable following the procedure.However, post completion of the procedure, the patient passed away.At the time of the incident, the patient had severe breathlessness, tachycardia, and cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed as per advanced cardiovascular life support (acls) protocol.The patient could not be revived and was declared deceased.It was noted that the timeframe between discovery of the issue to the corrective action and death was 15 to 20 minutes.The documented cause of death was acute coronary syndrome, acute inferior wall myocardial infarction (iwmi), cardiogenic shock, acute kidney injury (aki) with hyperkalemia, diabetes mellitus (dm) type ii, and hypertension.No autopsy was performed.The physician assessment of the relationship of the device and the patient death was not related.

Manufacturer Narrative

A2 age at time of event: 18 years or older.

Event Description

It was reported that a patient death occurred.The patient presented to the hospital with chest pain and anxiety for the last three days.An ecg was performed and confirmed acute inferior wall st elevation myocardial infarction (iwstemi).The patient underwent a coronary angiogram (cag), which revealed triple vessel disease.Vascular access was obtained via the femoral artery.A coronary angioplasty was performed on a 3.00mm x 34mm, moderately tortuous, and mildly calcified right coronary artery (rca).A 3.00 x 38 synergy drug eluting stent was advanced to the target lesion, and deployed.Significant resistance was encountered while advancing.The procedure was completed and the patient was stable following the procedure.However, post completion of the procedure, the patient passed away.At the time of the incident, the patient had severe breathlessness, tachycardia, and cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed as per advanced cardiovascular life support (acls) protocol.The patient could not be revived and was declared deceased.It was noted that the timeframe between discovery of the issue to the corrective action and death was 15 to 20 minutes.The documented cause of death was acute coronary syndrome, acute inferior wall myocardial infarction (iwmi), cardiogenic shock, acute kidney injury (aki) with hyperkalemia, diabetes mellitus (dm) type ii, and hypertension.No autopsy was performed.The physician assessment of the relationship of the device and the patient death was not related.It was later clarified that the severe breathlessness, tachycardia, cardiac arrest, cpr, and death all occurred after the synergy stent was implanted.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12421762
• MDR Text Key: 269777821
• Report Number: 2134265-2021-11246
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0027135660
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death