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 Chest Pain (1776); Ischemia (1942); Myocardial Infarction (1969)

Event Date 01/18/2022

Event Type  Death  

Event Description

It was reported that a patient death occurred.Vascular access was obtained via the radial artery.A percutaneous coronary intervention was performed on a left circumflex (lcx) to a long lesion located in the left anterior descending artery (lad).A non-boston scientific (bsc) 6f guide catheter and a non-bsc guidewire were used.A 28 x 2.75 promus premier select stent was advanced to the lcx for spot stenting.To cover the long lesion in the lad, a 2.5 x 38 synergy stent was deployed.Following stent deployment, a 2.5 x 12 non compliant balloon (nc) was advanced to post dilate the lesion.The procedure was completed with these devices.Immediately following the procedure, the patient experienced chest pain, and the vessel was noted to be totally occluded.The patient had experienced a myocardial infarction and ischemia, and the patient passed away.

Event Description

It was reported that a patient death occurred.Vascular access was obtained via the radial artery.A percutaneous coronary intervention was performed on a left circumflex (lcx) to a long lesion located in the left anterior descending artery (lad).A non-boston scientific (bsc) 6f guide catheter and a non-bsc guidewire were used.A 28 x 2.75 promus premier select stent was advanced to the lcx for spot stenting.To cover the long lesion in the lad, a 2.5 x 38 synergy stent was deployed.Following stent deployment, a 2.5 x 12 non compliant balloon (nc) was advanced to post dilate the lesion.The procedure was completed with these devices.Immediately following the procedure, the patient experienced chest pain, and the vessel was noted to be totally occluded.The patient had experienced a myocardial infarction and ischemia, and the patient passed away.

• 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: 13486509
• MDR Text Key: 285316923
• Report Number: 2134265-2022-01302
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0027569562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Sex: Female