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

Model Number	H7493941808220
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left anterior descending artery.A 2.25 x 8mm synergy xd drug-eluting stent was selected for use.However, it was noted that the stent detached from the delivery system.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Updated: b5.Describe event or problem, d10.Concomitant medical products and therapy dates, and h6.Device codes.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left anterior descending artery.A 2.25 x 8mm synergy xd drug-eluting stent was selected for use.However, it was noted that the stent detached from the delivery system.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.It was further reported that the 60% stenosed target lesion was located in the moderately calcified and moderately tortous left anterior descending artery.The stent dislodgement occurred outside the patient body.A 6f guidewire was also used.

• 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: 15287080
• Report Number: 2124215-2022-31635
• Device Sequence Number: 19402862
• Product Code: NIQ
• UDI-Device Identifier: 08714729980704
• UDI-Public: 08714729980704
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• 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: 01/05/2023
• Device Model Number: H7493941808220
• Device Lot Number: 0026639280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F .014 GUIDEZILLA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male