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

Lot Number	0030159408
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent got entrapped in the guide extension.The stenosed target lesion was located in the mildly tortuous and moderately calcified artery.A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device the stent got stuck in the guide extension.Upon trying to pull out the device, the struts of the stent were damaged.The procedure was completed via alternative method.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the stent got entrapped in the guide extension.The stenosed target lesion was located in the mildly tortuous and moderately calcified artery.A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device the stent got stuck in the guide extension.Upon trying to pull out the device, the struts of the stent were damaged.The procedure was completed via alternative method.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Device evaluated by mfr.Synergy xd mr us 3.50 x 12mm stent delivery system (sds); catheter was returned for analysis.Visual, tactile, microscopic and dimensional testing was performed on the device.A visual, tactile examination identified no issues with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A microscopic examination identified no issues with the hypotube shaft.A microscopic examination of the outer and inner lumen and mid-shaft section found no issues.Examination of the crimped stent via scope found evidence of stent damage.The proximal edge of the crimped stent had its struts lifted and bunched.There were no signs of movement and the stent was set between the proximal and distal markerbands.A microscopic examination of the bumper tip showed no signs of distal tip damage.The crimped stent od (outer diameter) was measured and was within maximum crimped stent profile measurement.No other device issues were identified during returned product analysis.

• 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: 18655503
• Report Number: 2124215-2024-01599
• Device Sequence Number: 7111617
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• 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,Followup
• Report Date (Section B): 03/28/2024

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: 0030159408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/28/2024
• 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 Sex: Unknown