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 H7493926012400

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

Patient Problems Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 08/10/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product.  complainant name: (b)(6) hospital.  device evaluated by mfr: the device was not received for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification.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

(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2016, clinical status assessment indicated that the patient's qualifying condition was unstable angina and the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 50% stenosis and was 6mm long with a reference vessel diameter of 4.0mm.The target lesion was treated with direct placement of 4.00x12mm synergy ii study stent.Following post-dilatation the residual stenosis was 0%.One day post procedure, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient died.Site has reported an event of "cardiac arrest; shock for ventricular tachycardia; lead to death." as per information received from the site, patient was given shock for the ventricular fibrillation episodes.The following day, the patient's wife was contacted, she said that "shock didn't work".

• 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: 6849785
• MDR Text Key: 85167528
• Report Number: 2134265-2017-08742
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: (01)08714729840077(17)20170829(10)19672342
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2017
• Device Model Number: H7493926012400
• Device Catalogue Number: 39260-1240
• Device Lot Number: 19672342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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: 80 YR