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

Model Number H7493919920300

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

Patient Problems Death (1802); Ventricular Tachycardia (2132); Heart Failure (2206); Ischemic Heart Disease (2493)

Event Date 02/08/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product.It is indicated that the device will not be returned for evaluation.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 specifications.The cause of the reported difficulties could not be determined.(b)(4).

Event Description

(b)(4) clinical study.Same case as mfr report#: 2134265-2017-09966, 2134265-2017-09967, 2134265-2017-09969.It was reported that following a coronary artery drug eluting stenting treatment procedure, the patient had ventricular tachycardia and expired.In (b)(6) 2013, clinical status assessment identified the patient¿s qualifying condition as stable angina (ccs classification 2).Abnormal fractional flow reserve (ffr) and abnormal stress test or imaging stress test indicated ischemia prior to procedure and the patient was referred for elective cardiac catheterization.Target lesion #1 was located in the mid right coronary artery (mid rca) with 75% stenosis and was 21 mm long with a reference vessel diameter of 3.00 mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00 x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was located in the distal left circumflex artery (lcx) 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 3.00 x 20 mm study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #3 was located in the proximal lcx with 60% stenosis and was 12 mm long with a reference vessel diameter of 3.00 mm.Target lesion #3 was treated with pre-dilatation and placement of a 3.00 x 20 mm study stent and post dilatation was performed.Following post-dilatation there was grade "a" dissection noted which was treated with placement of another 3.00 x 8 mm study stent with 0 % residual stenosis.The patient was discharged on dual antiplatelet therapy the next day.Per death certificate, in (b)(6) 2017, the patient died due to ventricular tachycardia.Immediate cause of death was ventricular tachycardia (1 hour onset to death) and underlying cause of death were heart failure with reduced ejection fraction (2 years onset to death), ischemic heart disease (5 years onset to death) and coronary artery disease (10 years onset to death).Site confirmed that the patient was not admitted to the hospital.The patient was taken to hospital er but passed within one hour of arrival.The patient was given "cardiopulmonary resuscitation" (cpr) as an action taken.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6959993
• MDR Text Key: 89681054
• Report Number: 2134265-2017-09968
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2013
• Device Model Number: H7493919920300
• Device Lot Number: 15671416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2012
• 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: 61 YR