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

Model Number	H7493941816300
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that seal was compromised.A 3.00 x 16mm synergy xd drug-eluting stent was selected for use.However, it was noted that the stent was open in the box.
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.Device evaluated by mfr.: a synergy xd mr us 3.00 x 16mm packaging complaint was returned for analysis.The vendor seal of the inner pouch was opened.Visual examination of the outer box shows the closure strip had been torn open.No other damage was observed.An examination of the inner foil pouch identified a crease/bend was evident on the right side of the foil pouch.An examination identified that the vendor seal on the pouch was partially opened.There was a clear impression of where the vendor seal was present at the opened section of the pouch.The left side corner remained sealed.The delivery system remained within the protective hoop.Two photos were also provided by the customer.A review of these photo images shows the inner foil pouch opened.Returned media confirms the reported allegation.
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.
Event or Problem Description
It was reported that seal was compromised.A 3.00 x 16mm synergy xd drug-eluting stent was selected for use.However, it was noted that the stent was open in the box.

• 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: 23885144
• Report Number: 2124215-2025-92839
• Device Sequence Number: 9650519
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: (01)08714729980964(17)270526(10)36670511
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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 Model Number: H7493941816300
• Device Catalogue Number: H7493941816300
• Device Lot Number: 0036670511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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
• Patient Sex: Unknown