MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE SYNERGY¿ CORONARY DRUG-ELUTING STENT

Model Number H7493919928300

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Myocardial Infarction (1969); Reocclusion (1985)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

Complainant name: (b)(6). Age at the time of event: 18 years or older. 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

(b)(4) clinical study. It was reported that in-stent restenosis and myocardial infarction occurred. In (b)(6) 2013, clinical status assessment identified the patient's qualifying condition as silent ischemia. Prior to procedure, the patient was found to have abnormal stress test or imaging stress test indicative of ischemia and the subject was referred for cardiac catheterization. Index procedure was performed on the same day. Target lesion was located in the distal right coronary rca (cass site # 3) with 75% stenosis, and was 23 mm long with a reference vessel diameter of 3 mm. The target lesion was treated with pre-dilatation, placement of a 3 x 28 mm study stent. Following post-dilatation the residual stenosis was 0%. The following day, the patient was discharged on dual antiplatelet therapy. In (b)(6) 2016, the patient experienced silent myocardial infarction. The 90% stenosis in the distal rca was treated with placement of drug eluting stent. Post procedure, the residual stenosis was 0% with timi 3 flow.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the patient was diagnosed with silent myocardial ischemia and not silent myocardial infarction as previously reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the study stent is not related to the event of silent myocardial ischemia.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6194752
• MDR Text Key: 62992966
• Report Number: 2134265-2016-12073
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (Y/N): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/21/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 10/16/2013
• Device MODEL Number: H7493919928300
• Device LOT Number: 15690418
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 12/06/2012
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/21/2016 Patient Sequence Number: 1