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

Model Number H7493926216250

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

Patient Problems Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Occlusion (1984); ST Segment Elevation (2059); Ventricular Tachycardia (2132)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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

(b)(6) study.It was reported that post a stenting treatment procedure, the patient experienced myocardial infarction and ventricular tachycardia.In (b)(6) 2016 the patient presented with stable angina (ccs classification-2) and was further referred for cardiac catheterization.On the same day, the index procedure was performed.Target lesion #1 was located in the mid right coronary artery (rca) (cass site #2) with 75% stenosis and was 8 mm long with a reference vessel diameter of 3.5 mm.Target lesion #1 was treated with direct placement of a 3.50 x 12 mm study stent with 0% residual stenosis.Target lesion #2 was located in the mid left anterior descending artery (lad) (cass site #13) with 85% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.Target lesion #2 was treated with pre-dilatation and placement of a 2.50 x 16 mm study stent.Following post dilatation, residual stenosis was 0%.Two hours post index procedure, the subject was noted to have non-persistent ventricular tachycardia, with thoracic complaints and electrocardiogram (ecg) revealed temporary st segment elevations.The subject was further recommended for repeat angiography.Coronary angiography revealed good outcome in the lesion treated.However, small occlusion in the second diagonal branch originating from the stent that is deployed in mid lad and moderate grade stenosis in the transitional area from the mid to distal lad were noted.Intervention was not required in either of the cases.On the same day, the non-persistent ventricular tachycardia was considered by the hospital to be resolved.One day later, cardiac enzyme levels were noted to be elevated and the myocardial infarction was considered by the hospital to be resolved.Three days post index procedure, the subject was discharged on aspirin and clopidogrel.

• 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: 6185112
• MDR Text Key: 62703574
• Report Number: 2134265-2016-11860
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2017
• Device Model Number: H7493926216250
• Device Catalogue Number: 39262-1625
• Device Lot Number: 19321140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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): Other
• Patient Age: 76 YR