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

Model Number	H7493941848300
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that detachment and removal difficulties occurred.The 80-90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).After a non-boston scientific guide catheter passed the ostium of the rca, a dissection was noted in the proximal rca.Right after the dissection was ballooned and stented, a rotapro and shockwave balloon were used on the mid to distal rca.A 3.00 x 48mm synergy xd drug-eluting stent was then advanced to treat the mid rca.However, the stent was noted to be stuck in the lesion.When the physician tried to remove the device, the stent and stent balloon sheared off from the delivery system.An attempt to snare the detached piece, but the snare would not pass the guide extension catheter.Anesthesia, intubation, and open-heart surgery were required to remove the detached fragment.No patient complications were reported, and the patient was recovered and was discharged home.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21269904
• Report Number: 2124215-2025-02891
• Device Sequence Number: 8157416
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: 08714729985228
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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
• Report Date (Section B): 01/29/2025

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: 06/24/2026
• Device Model Number: H7493941848300
• Device Catalogue Number: H7493941848300
• Device Lot Number: 0034353630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/29/2025
• 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 Age: 75 YR
• Patient Sex: Male