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

Model Number	H7493941824400
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	10/15/2021
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 moderately tortuous and severely calcified proximal right coronary artery.A 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent detached from the balloon and was dislodged inside the patient.The physician tried to rewire and remove the detached stent but removal was unsuccessful.The dislodged stent was then crushed within the lesion by additional stenting.The procedure was completed with a different synergy drug-eluting stent.No patient complications were reported and the patient was doing well post-procedure.
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery.A 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent detached from the balloon and was dislodged inside the patient.The physician tried to rewire and remove the detached stent but removal was unsuccessful.The dislodged stent was then crushed within the lesion by additional stenting.The procedure was completed with a different synergy drug-eluting stent.No patient complications were reported and the patient was doing well post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 4.00 x 24mm stent delivery system was returned for analysis.The device was returned and no stent present.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was 0.0479.This is within max crimped stent profile measurement.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12698166
• Report Number: 2134265-2021-13427
• Device Sequence Number: 4445062
• Product Code: NIQ
• UDI-Device Identifier: 08714729981145
• UDI-Public: 08714729981145
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 12/08/2021

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: 05/25/2023
• Device Model Number: H7493941824400
• Device Lot Number: 0027456192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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