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 H7493926038300

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Death (1802); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 02/14/2017

Event Type  Death  

Manufacturer Narrative

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: 2134265-2017-01775 and 2134265-2017-01777.It was reported that the patient experienced thrombosis, chest pain, st elevations and expired.The patient presented with a st elevated myocardial infarction.The target lesion was located in the 90% stenosed, mildly tortuous and mild to moderately calcified right coronary artery (rca).Three synergy ii stents were implanted overlapping in the rca; a 3.00 x 38 in the proximal to mid rca, another 3.00 x 38 in the mid rca, and a 3.50 x 12 in the distal rca.The procedure was completed and heparin bivalirudin, and clopidogrel blood thinning medication was administered.The patient was in recovery for 2-3 hours when chest pain and st elevations occurred.The patient was transferred back to the cardiac cath lab for treatment.The following day all 3 stents had complete thrombosis and angiojet thrombectomy was performed, however the patient expired.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6393872
• MDR Text Key: 69554446
• Report Number: 2134265-2017-01776
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: (01)08714729840411(17)20170928(10)19825555
• 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
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: H7493926038300
• Device Catalogue Number: 39260-3830
• Device Lot Number: 19825555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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): Death