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

Model Number	10602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the moderately tortuous right coronary artery which had a previous old stent.A 3.50 x 16mm synergy ii drug eluting stent was introduced with the help of a non-boston scientific guide extension catheter but the stent would not advance.Upon removal, the stent caught and dislodged in the top of the extension catheter.A small balloon was advanced to the tip and inflated to remove the dislodged stent.The procedure was successfully completed with a different device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 3.50 x 16mm stent delivery system (sds) was returned for analysis.The stent was not returned.The balloon appeared as if it had been subjected to positive pressure.No damage was noted on the balloon.Clear hardened media was visible inside the balloon.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The device was soaked overnight at 37degrees to facilitate a guidewire interaction test.A 0.014 test guidewire loaded successfully.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the moderately tortuous right coronary artery which had a previous old stent.A 3.50 x 16mm synergy ii drug eluting stent was introduced with the help of a non-boston scientific guide extension catheter but the stent would not advance.Upon removal, the stent caught and dislodged in the top of the extension catheter.A small balloon was advanced to the tip and inflated to remove the dislodged stent.The procedure was successfully completed with a different device.There were no patient complications.

• 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: 12109326
• Report Number: 2134265-2021-08496
• Device Sequence Number: 4203149
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 08/24/2021

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: 11/03/2022
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0026356096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1