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

Model Number 10618

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

Patient Problems Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Thrombosis/Thrombus (4440)

Event Date 03/02/2022

Event Type  Death  

Event Description

It was reported that a patient death occurred. An angioplasty was performed on the left main (lm) artery. A 4. 00 x 16 synergy stent was deployed in the lm artery. The patients blood pressure started to fall and abnormal electrocardiography (ecg) changes were observed. An angiogram was performed to view the lm flow, and a clot was observed in the lm. Another stent was deployed to regain flow in the lm, however, the patient passed away at the end of the procedure. It was noted that the cause of death was due to clot in the left main artery. It was further reported that the patient presented with acute chest pain, perspiration, and low blood pressure. After the 4. 00x16 synergy stent was implanted, the lesion was post dilated with a 5. 0 x 6mm balloon at 20mm pressure. Thirty minutes later while the patient was still on the cath table, the falling blood pressure ecg changes were observed. An attempt was made to deploy another stent, however, the patient passed away during the attempt to revascularize the left main artery.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14047136
• MDR Text Key: 288829273
• Report Number: 2134265-2022-04115
• 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

• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0026758331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/07/2022 Patient Sequence Number: 1