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

Model Number	H7493941828250
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty and stent migration occurred.The target lesion was located in the proximal left anterior descending artery into left main.A 2.50 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, it was noted that difficulty was encountered while attempting to pulled back the stent into the left main artery by another device after deployment.The target lesion was treated by open-heart surgery after failed retrieval of the stent.Additionally, the device became unraveled after deployment by another product that entered afterward, causing migration.The procedure was completed by leaving the stent where it was.Patient was stable at the time of the procedure.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter zip/post code: (b)(6).
Event or Problem Description
It was reported that removal difficulty and stent migration occurred.The target lesion was located in the proximal left anterior descending artery into left main.A 2.50 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, it was noted that difficulty was encountered while attempting to pulled back the stent into the left main artery by another device after deployment.The target lesion was treated by open-heart surgery after failed retrieval of the stent.Additionally, the device became unraveled after deployment by another product that entered afterward, causing migration.The procedure was completed by leaving the stent where it was.Patient was stable at the time of the procedure.It was further reported that the stent delivery catheter was removed like normal.Then the deployed stent was pulled back into the left main and when they also tried to snare the stent out because of where it got pulled into the left main.
Additional Manufacturer Narrative
H6: device code: updated device code based on gfe response.E1: initial reporter phone: (b)(6).

• 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: 21960755
• Report Number: 2124215-2025-25879
• Device Sequence Number: 9198071
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: (01)08714729980834(17)260828(10)34851269
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Model Number: H7493941828250
• Device Catalogue Number: H7493941828250
• Device Lot Number: 0034851269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 08/28/2024
• 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
• Patient Sex: Unknown