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

Model Number 10623

Device Problems Premature Activation (1484); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported that stent moved on balloon occurred.Vascular access was obtained via the radial artery.The non-totally occluded, 3.0mm x 36mm, concentric, de novo target lesion was located in the mildly tortuous and severely calcified left circumflex artery.A 3.00 x 38 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the stent as about to come off the balloon and expand as soon as it reached the lesion, not at the most ideal position.The procedure was completed with the device, however.There were no patient complications nor injuries reported and the patient status was stable.

Event Description

It was reported that stent moved on balloon occurred.Vascular access was obtained via the radial artery.The non-totally occluded, 3.0mm x 36mm, concentric, de novo target lesion was located in the mildly tortuous and severely calcified left circumflex artery.A 3.00 x 38 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the stent was about to come off the balloon and expand as soon as it reached the lesion, not at the most ideal position.The procedure was completed with the device, however.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that there was some difficulty advancing the device in the guide catheter but no difficulty advancing over the wire.A guidezilla guide extension catheter was in use at the time of the event and there was contact between the synergy and the guidezilla.No accidental pressure was applied to the delivery system while inside the patient.The stent was deployed and partially covered the target lesion.A 3.00 x 19 stent was implanted to cover the remainder of the lesion.It was further reported that there was difficulty advancing the device in the guide catheter.Another stent was implanted to cover the uncover part of the lesion.

• 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: 12961798
• MDR Text Key: 281991870
• Report Number: 2134265-2021-15600
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TW
• 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
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0026940895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Male