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 H7493926012220

Device Problem Occlusion Within Device (1423)

Patient Problems Thrombus (2101); Sudden Cardiac Death (2510)

Event Date 03/09/2017

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; therefore a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id# 2134265-2017-04352, 2134265-2017-04353 and 2134265-2017-04354.(b)(4) study.It was reported that patient death and in-stent thrombus occurred.In (b)(6) 2016, the patient was referred for cardiac catheterization and subsequently the index procedure was performed.Target lesion #1 was located in the mid left anterior descending artery (lad) with 70% stenosis and was 26 mm long with a reference vessel diameter of 2.50 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.25 x 38 mm synergy ii stent.Following post dilatation, the residual stenosis was 0%.Target lesion #2 was located in the proximal lad with 80% stenosis and was 20 mm long with a reference vessel diameter of 3.00 mm.Target lesion #2 was treated with pre-dilatation and placement of a 2.5 x 28 mm synergy ii stent.Following post dilatation, the residual stenosis was 0%.Target lesion #3 was located in the first obtue marginal branch (om1) with 80% stenosis and was 16 mm long with a reference vessel diameter of 2.25 mm.Target lesion #3 was treated with pre-dilatation and placement of a 2.25 x 16 mm and a 2.25 x 12 mm synergy ii stent with 0% residual stenosis.The following day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient expired at home due to sudden "cardiac death", assumed to be attributable to de novo coronary thrombosis or in-stent coronary thrombosis, approximately 36 hours after stopping the anti-platelet drug plavix (clopidogrel).No death certificate is available and autopsy was not performed.

• 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: 6534587
• MDR Text Key: 74094400
• Report Number: 2134265-2017-04355
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: (01)08714729840022(17)20170621(10)19443466
• 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: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2017
• Device Model Number: H7493926012220
• Device Catalogue Number: 39260-1222
• Device Lot Number: 19443466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2016
• 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
• Patient Age: 83 YR