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

Lot Number	0032789498
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.Synergy xd mr us 4.00 x 48mm stent delivery system was returned for analysis.Visual and tactile inspection found no issues with the hypotube shaft and no issues with the outer / mid-shaft sections or the inner lumen of the device.Visual/tactile and microscopic analysis revealed the stent struts from the mid-section, were stretched and pulled over distal balloon cone and bumper tip.Balloon cones were reviewed via microscopic analysis, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip showed no signs of distal tip damage.Dimensional analysis measured the undamaged crimped stent outer diameter, and the result is within max crimped stent profile measurement.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that the stent dislodged outside the patient.During preparation, a 4.00 x 48mm synergy xd drug-eluting stent was advanced to treat the lesion.However, upon opening the package, the stent came off the balloon and was damaged.The procedure was completed with another of the same device without any patient complications.
Event or Problem Description
It was reported that the stent dislodged outside the patient.During preparation, a 4.00 x 48mm synergy xd drug-eluting stent was advanced to treat the lesion.However, upon opening the package, the stent came off the balloon and was damaged.The procedure was completed with another of the same device without any patient complications.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19588272
• Report Number: 2124215-2024-37094
• Device Sequence Number: 17971423
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 10/23/2025
• Device Lot Number: 0032789498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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