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

Model Number 10619

Device Problems Fracture (1260); Obstruction of Flow (2423)

Patient Problem Thrombosis (2100)

Event Date 10/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that acute stent thrombosis and stent fracture occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 3.00x20mm synergy drug-eluting stent was deployed to treat the lesion.After the physician inserted the stent into the lesion, dilatation was conducted with the original stent balloon.However, it was noted that a slight thrombus was found in the lesion where the stent was inserted and the strut of the stent was fractured.Following post dilatation with a non-bsc non-compliant balloon, the fracture of the strut was more clearly visible.The procedure was completed with a longer 3.0x28mm synergy drug-eluting stent.No further patient complications were reported and the patient was stabilized.The patient was safely treated and discharged.After three days follow-up examination showed that there was still a small amount of thrombus left.The physician decided to take an angiography after six months and watch the patient's progress.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8013693
• MDR Text Key: 125283853
• Report Number: 2134265-2018-62199
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2019
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0022262514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• 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: 51 YR