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

Model Number 10617

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

Patient Problems Cardiac Enzyme Elevation (1838); Reocclusion (1985)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: the date of the event is unknown.Bsc became aware of the event on 21-nov-2019.A date of (b)(6) 2019 was entered to indicate that the event occurred on an unknown day in (b)(6) 2019.Device is a combination product.

Event Description

It was reported stent restenosis and stent thrombosis occurred.The patient presented with acute coronary syndrome (acs) with troponin elevation.In stent restenosis of a previously implanted synergy stent (2008) was observed.The stent was noted to be very occluded.The physician proceeded with balloon angioplasty and a 3.0 x 12 non bsc stent.A severe joint at the ostial lad neo lesion was found.He pre dilated and placed a 3.5 x 20mm synergy megatron stent with satisfactory results.The patient was put on aspirin and brillique and remained hospitalized.Two days post procedure, the patient relapsed, but recovered each time.A battery implantation was discussed.The next day, the patient experienced atrioventricular blockage and the tension dropped several time as +/- tension.Four days post procedure, the patient had the battery implantation.Five days post procedure the physician performed angiography and the synergy megatron stent was noted to be thrombosed.Aspiration was performed.The left ventricle was as 40%.The patient recovered and the procedure was completed okay.The physician felt the thrombosis occurred due to degraded hemodynamic conditions following atrioventricular blockage.It was noted that the lesion was 80% stenosed after the hemodynamics were modified.It was additionally noted that the event was not thrombosis of the megatron, but was due to the hemodynamic which where modified after the atrial tachycardia.The patient was reported to be stable following the procedure.

• 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: 9468375
• MDR Text Key: 170751935
• Report Number: 2134265-2019-15774
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention