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

Model Number	H7493941838300
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	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the non-tortuous and mildly calcified vessel.A 3.00 x 38mm synergy xd drug-eluting was advanced for treatment.However, the stent was unable to deploy due to calcium and when the device was tried to pull back, the stent came off from the balloon in left main artery.The stent balloon was reinflated to remove the dislodged stent.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the non-tortuous and mildly calcified vessel.A 3.00 x 38mm synergy xd drug-eluting was advanced for treatment.However, the stent was unable to deploy due to calcium and when the device was tried to pull back, the stent came off from the balloon in left main artery.The stent balloon was reinflated to remove the dislodged stent.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 3.00 x 38mm stent delivery system was returned for analysis.The device was returned without the stent attached.A review of the manufacturing stent profile data was performed and the stent outer diameter is within max crimped stent profile measurement.The balloon cones were reviewed, and there were no signs of positive pressure applied.Crimp markings were visible.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found no issues along the shaft.No other issues noted with device.

• Brand Name: SYNERGY XD
• Common Device Name: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15825854
• Report Number: 2124215-2022-47827
• Device Sequence Number: 17669551
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 06/14/2023
• Device Model Number: H7493941838300
• Device Lot Number: 0027548932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown