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

Model Number	H7493941812300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged when attempting to reposition the device.The stent was removed with a snare.The procedure was successfully completed.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged when attempting to reposition the device.The stent was removed with a snare.The procedure was successfully completed.No patient complications were reported.It was further reported that the procedure was completed with balloon angioplasty.
Additional Manufacturer Narrative
The synergy xd mr us 3.00 x 12mm stent delivery system was returned for analysis.The device was returned with an additional device (snare) with damaged stent attached to wire loop of snare and not to the device.The balloon cones were reviewed.The balloon was found to be in a deflated state with crimp markings visible.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found 2 kinks measured at 4.5cm and 7.5cm proximal to distal tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged when attempting to reposition the device.The stent was removed with a snare.The procedure was successfully completed.No patient complications were reported.It was further reported that the procedure was completed with balloon angioplasty.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14579018
• Report Number: 2134265-2022-06172
• Device Sequence Number: 5065410
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: 08714729980957
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: H7493941812300
• Device Lot Number: 0027134934
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 07/08/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/10/2022; 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White