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

Model Number 10632

Device Problems Break (1069); Positioning Failure (1158); Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 95% stenosed target lesion was located in the left anterior descending artery.A 2.50 x 48 synergy drug-eluting stent was advanced for treatment.However, upon inflation, the stent did not expand even after repeated attempts.The inflation device was changed but the balloon still could not inflate.The stent was pulled out and it was noted that the hypotube was broken and there was leakage.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that shaft break occurred.The 95% stenosed target lesion was located in the left anterior descending artery.A 2.50 x 48 synergy drug-eluting stent was advanced for treatment.However, upon inflation, the stent did not expand even after repeated attempts.The inflation device was changed but the balloon still could not inflate.The stent was pulled out and it was noted that the hypotube was broken and there was leakage.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the lesion was non-tortuous and non-calcified.The hypotube broke about 90-100cm from the hub.The physician removed the device by just pulling it back.

Event Description

It was reported that shaft break occurred.The 95% stenosed target lesion was located in the left anterior descending artery.A 2.50 x 48 synergy drug-eluting stent was advanced for treatment.However, upon inflation, the stent did not expand even after repeated attempts.The inflation device was changed but the balloon still could not inflate.The stent was pulled out and it was noted that the hypotube was broken and there was leakage.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the lesion was non-tortuous and non-calcified.The hypotube broke about 90-100cm from the hub.The physician removed the device by just pulling it back.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13805348
• MDR Text Key: 287532978
• Report Number: 2134265-2022-02813
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0027527210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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