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

Model Number 10632

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2021

Event Type  Injury  

Event Description

It was reported that stent fracture occurred requiring additional intervention.The 95% stenosed, de novo target lesion was located in the non-tortuous and moderately calcified left anterior descending artery.The lesion was predilated with a 2x10mm nc balloon catheter and a 2.50x48mm synergy ii drug-eluting stent was deployed for treatment.However, in the proximal part of the stent, a fracture was noted.Another 3.0 x 16 synergy was implanted to cover the fractured stent.There were no patient complications nor injuries reported and the patient status was stable.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12091868
• MDR Text Key: 259132840
• Report Number: 2134265-2021-08257
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0026481820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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