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

Lot Number	0030141059
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 3.00 x 12mm was returned for analysis.A visual, tactile and microscopic examination of the hypotube found a break at the laser cut region.The break was contained in the mid-shaft extrusion.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.A microscopic examination revealed there was no sign of damage, stretching or lifting of the stent struts.There were no signs of stent movement, and the stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that crossing difficulties and shaft kink were encountered.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified distal left anterior descending artery.A 3.00 x 12mm synergy xd drug-eluting stent was advanced but failed to cross the lesion and a kink was noted on the mid shaft.The device was removed intact, and the procedure was completed with a non-boston scientific device.No patient complications were reported.However, returned device analysis revealed hypotube lasercut region detachment.

• 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: 19397633
• Report Number: 2124215-2024-31754
• Device Sequence Number: 12499269
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: 08714729980957
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: 09/05/2024
• Device Lot Number: 0030141059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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 Age: 87 YR
• Patient Sex: Male