MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10606

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent thrombosis and st-segment elevation occurred. The patient was given aspirin, plavix 300mg, tenecteplase (tnkase), heparin bolus and drip additional heparin given in central venous line. The target lesions were located in the proximal left anterior descending artery and mid circumflex artery. Subsequently, two synergy ii drug-eluting stents were implanted in the target lesions 95 and 112 minutes after tnkase. However, electrocardiogram showed st-segment elevation 5 hours after stent placement. The patient was sent back to lab and it was noted that both stents were occluded. The clot was removed, stents were placed and patient was given an integrilin and brilinta. Ejection fraction (ef) is 20-25% and no further chest pain was experienced prior to discharge. Follow-up clinic visit stated that patient is wearing a lifevest.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8749202
• MDR Text Key: 149670433
• Report Number: 2134265-2019-07037
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/02/2020
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0023082410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/01/2019 Patient Sequence Number: 1