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

Model Number 10623

Device Problem Obstruction of Flow (2423)

Patient Problems Thrombosis (2100); No Code Available (3191)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: used the 1st day of the month of the bsc aware date as no event date was provided.(b)(6).Device is a combination product.

Event Description

It was reported that patient experienced acute thrombosis.After placing a synergy drug-eluting stent, an acute thrombosis occurred.No further patient complications were reported.

Event Description

It was reported that patient experienced acute thrombosis.After placing a synergy drug-eluting stent, an acute thrombosis occurred.No further complications were reported.It was further reported that the 100% stenosed, 3.5x38mm, de novo, type c, thrombotic target lesion was located in the mid right coronary artery (rca).After aspirating thrombus of right posterior descending artery and mid rca, intravenous ultrasound (ivus) was performed and the lesion was pre-expanded with 3.5x10m wolverine cutting balloon.A 4.00x38mm synergy ii drug-eluting stent was placed at 14 atmospheres.After ivus confirmation, the procedure was completed.On the same day, a stent thrombus was found.As a treatment, an aspiration of thrombus was perfomed and additional dilatation was performed with a 4mm non-compliant balloon.No patient complications were reported and the patient's status was good.As per physician's comment, thrombocytosis was observed, suggesting that thrombocythemia may have caused thrombus in th stent.It was considered that it was more likely due to patient factors than thrombosis due to stent.

Manufacturer Narrative

(b3) date of event: updated from the 1st day of the month of the bsc aware date to 07/02/2020.(e1) initial reporter city: (b)(6).Device is a combination product.

• 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: 10328680
• MDR Text Key: 200602190
• Report Number: 2134265-2020-09251
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2021
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0024594065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR