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

Model Number H7493926216300

Device Problems Stent (515); Fracture (1260)

Patient Problems Angina (1710); Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product. (b)(4). 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

It was reported that stent fracture, chest pain and angina occurred. The target lesion was located in a coronary artery. A 3. 00x16mm synergy¿ drug-eluting stent was implanted to treat the lesion. However, a few days later, the patient returned to the hospital due to chest pain and angina. Coronary angiography revealed that the implanted stent was fractured and was bent inside the vessel. A non-bsc stent was implanted inside the fractured synergy stent and the patient was discharged home. No further patient complications were reported. The physician noted this likely occurred due to the pressure and angle of the vessel.

• 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: 6194650
• MDR Text Key: 62979355
• Report Number: 2134265-2016-12200
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (Y/N): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/14/2016

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?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: H7493926216300
• Device Catalogue Number: 39262-1630
• 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: 12/14/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• 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