MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926028400

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Ventricular Fibrillation (2130); Vomiting (2144); Cardiogenic Shock (2262); Respiratory Failure (2484); Complete Heart Block (2627)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-01694, 2134265-2016-02196, and 2134265-2016-02197.It was reported that stent thrombosis occurred.The target lesion was located in the right coronary artery (rca).An optical coherence tomography (oct) guiding catheter was used to deploy four synergy ii drug-eluting stents sized 4.00 x 20, 4.00 x 28, 4.00 x 24, and 4.00 x 8.The procedure was completed with very good results.The patient was sent to the intensive care unit (icu) and within an hour and a half, the patient went into ventricular fibrillation, developed cardiogenic shock and respiratory failure, and was subsequently sent back to the catheter laboratory.It was noted that the implanted synergy stents had clotted off.A non-bsc extraction catheter and angiojet thrombectomy catheter were then advanced to extract the clot, and a temporary pacer and a non-bsc ventricular assistive device was placed for support.The procedure was completed with no further patient complications reported, but the patient's status was critical post procedure.The patient remains hospitalized and in stable status with chronic kidney injury.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient presented to the emergency room with a 6 day history of left sided upper chest pain with worsening in frequency and intensity, diagnosed as unstable angina.The index procedure was performed on the same day the patient presented to the emergency room.During the index procedure, prior to stent placement, two passes of aspirational thrombectomy with a non-bsc catheter were performed, yielding a small amount of dark red thrombus.The mid and distal right coronary artery was treated with multiple inflations from 3 different non-bsc balloon catheters.After initial angioplasty, the mid and distal rca are diffusely diseased with long areas of 70-80% stenosis in the mid vessel and focal 70-80% in the distal vessel.The stent balloons were used to perform post dilatation of the stents and the overlap zones in multiple inflations p to 16 atms.The physician was unable to pass longer stents due to the tortuosity, so multiple short stents had to be used.There was evidence of st elevation with no reflow distally after opening the artery.This was treated with intracoronary nitroglycerin.At the time of the event, the patient vomited and received acls, defibrillation and intubation at bedside.The patient was in complete heart block and receiving dopamine an dobutamine upon arrival to the cath lab.The aspiration thrombectomy catheters removed a large amount of red and while thrombus, even more than removed earlier in the day.A small amount of residual thrombus was left in the distal rca.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5505052
• MDR Text Key: 40522805
• Report Number: 2134265-2016-01695
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2016
• Device Model Number: H7493926028400
• Device Catalogue Number: 39260-2840
• Device Lot Number: 18345902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR