MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10602
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on the balloon.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery (rca).The physician had difficulty getting down to the lesion with an apex and nc balloon catheters.So, the physician decided to use a 6f guideliner guide extension catheter to deliver the devices easier and was able to deliver the nc and compliant balloons.After a percutaneous old balloon angioplasty was performed, a 3.50 x 16 synergy drug-eluting stent was advanced; however, the stent could not be delivered to the calcified area after pushing a couple of times.The stent was pulled out and the guideliner was tried to advance down the vessel with the apex balloon and reached the mid rca.The synergy stent was advanced to the lesion and it was noticed that there was no stent on the stent delivery system.The stent was found via x-ray to be in the guide catheter on the stent balloon shaft inside the aorta.The device was pulled out of the patient's body and completed the procedure with a 3.0x16 synergy stent.No patient complications were reported.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12263394
• Report Number: 2134265-2021-09908
• Device Sequence Number: 4066795
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0027068391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1