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

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

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

It was reported that chest pain and stent thrombosis occurred.The patient presented with inferior st-segment elevation myocardial infarction (stemi).The target lesion was located in the distal right coronary artery (rca).After pre-dilatation with a 2.5x12mm emerge balloon catheter, a 3.0x20mm synergy¿ drug-eluting stent was deployed to treat the lesion.Post-dilatation was performed with a 3.5x12mm emerge balloon catheter and the procedure was completed.However, the following day, the patient returned with chest pain and inferior st-segment elevation.The physician found that the previously implanted 3.0x20mm synergy¿ stent was occluded.Subsequently, the lesion was dilated and a 3.0x32mm synergy¿ stent was deployed in the distal rca and a 3.0x20 synergy¿ stent was deployed in the mid rca.Post-dilatation was performed with a 3.5 nc emerge balloon catheter and the procedure was completed.No further complications were reported, the patient's status was well, and the patient was returned to the cardiac unit.

• 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: 6351932
• MDR Text Key: 68082918
• Report Number: 2134265-2017-01358
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR