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

Lot Number	0030105343
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter: address 1: (b)(6).Device evaluated by mfr.Synergy xd mr was returned for analysis.A visual and tactile examination identified multiple hypotube kinks along the length of the hypotube shaft.Examination of the stent found issues.A kink in the stent was identified.The stent moved position and has been pulled distally over onto the distal markerband.Stent was found moved distally over balloon cones and situated over the distal markerband.No other device issues were identified during returned product analysis.
Event or Problem Description
Reportable based on device analysis completed on 19-jan-2024.It was reported that crossing difficulties were encountered.The stenosed target lesion was located in the severely tortuous artery.A 2.25 x 12mm synergy xd drug eluting stent was advanced into the lesion but failed to cross.The device was removed , and the procedure was completed with a different method.No patient complications were reported.However, returned device analysis revealed a stent moved on balloon.

• 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: 18717601
• Report Number: 2124215-2024-07675
• Device Sequence Number: 15103646
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: 08714729980711
• Combination Product (Y/N): Y
• 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): 02/15/2024

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: 08/29/2024
• Device Lot Number: 0030105343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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