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

Model Number	H7493941828250
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement and stent damage occurred resulting in additional intervention.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified right coronary artery (rca).A 2.50 x 28mm synergy xd drug-eluting stent was advanced through a previously implanted 2.50x28 synergy stent for treatment.However, it was noted that the stent was caught on the implanted stent and dislodged from the balloon.The stent became lodged into the ostial rca and both stents were noted to be damaged.The stent was snared and removed from the patient successfully.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: synergy xd mr us 2.50 x 28mm stent delivery system was returned for analysis.The device was returned without the stent.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and the folds were noted to be relaxed and crimp stent markings were visible on the balloon body.The balloon was noted to contain traces of contrast media inside the balloon.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues noted with device.
Event or Problem Description
It was reported that stent dislodgement and stent damage occurred resulting in additional intervention.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified right coronary artery (rca).A 2.50 x 28mm synergy xd drug-eluting stent was advanced through a previously implanted 2.50x28 synergy stent for treatment.However, it was noted that the stent was caught on the implanted stent and dislodged from the balloon.The stent became lodged into the ostial rca and both stents were noted to be damaged.The stent was snared and removed from the patient successfully.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 15080366
• Report Number: 2134265-2022-07723
• Device Sequence Number: 14466967
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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): 09/08/2022

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: 10/14/2023
• Device Model Number: H7493941828250
• Device Lot Number: 0028250778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown