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

Model Number	10603
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage and stent dislodgment occurred.A percutaneous coronary intervention was being performed.The 90% stenosed target lesion was located in the tortuous and calcified circumflex artery.The lesion was predilated with another manufactures 2.5x12 balloon.A 3.00 x 20 synergy drug-eluting stent was advanced through a non-bsc guide extension catheter to treat the lesion.However, when the physician tried to put the stent through the extension catheter, the stent would not go.The guideliner, the guide wire and the stent were removed as a whole from the patient's body and it was noticed that the stent was damaged and off the balloon.It appeared that the stent was intact and nothing was left in the vessel.The procedure was completed with balloon dilation.No patient complications were reported.
Additional Manufacturer Narrative
Updated b5: describe event or problem.Device evaluated by mfr.: synergy ii us mr 3.00 x 20mm stent delivery system (sds) was returned for analysis.There was no stent returned with this device.The maximum crimped stent profile measurement.The balloon cones were reviewed; balloon wings appear tightly wrapped and crimp markings are visible on the balloon walls.A visual and microscopic examination of the bumper tip showed evidence of tip damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.
Event or Problem Description
It was reported that stent damage and stent dislodgment occurred.A percutaneous coronary intervention was being performed.The 90% stenosed target lesion was located in the tortuous and calcified circumflex artery.The lesion was predilated with another manufactures 2.5x12 balloon.A 3.00 x 20 synergy drug-eluting stent was advanced through a non-bsc guide extension catheter to treat the lesion.However, when the physician tried to put the stent through the extension catheter, the stent would not go.The guideliner, the guide wire and the stent were removed as a whole from the patient's body and it was noticed that the stent was damaged and off the balloon.It appeared that the stent was intact and nothing was left in the vessel.The procedure was completed with balloon dilation.No patient complications were reported.It was further reported that the target lesion has moderate calcium and tortuousity was sited.A 6f guideliner was used during procedure.

• 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: 11309608
• Report Number: 2134265-2021-01078
• Device Sequence Number: 3256604
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: 08714729840176
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 03/15/2021

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: 09/16/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0026094579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1