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

Model Number	H7493941816220
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 98% stenosed target lesion was located in the severely tortuous and moderate to severely calcified mid obtuse marginal artery.A 2.25 x 16mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.During the procedure as the stent was being force to cross the lesion, the mid shaft was broke in half.A guidezilla catheter and a telescope were used to assist the stent to cross the lesion but the attempt was not successful.The device was removed intact by pulling it out.The procedure was performed with angioplasty and was completed.There were no patient complications reported.
Event or Problem Description
It was reported that a shaft break occurred.The 98% stenosed target lesion was located in the severely tortuous and moderate to severely calcified mid obtuse marginal artery.A 2.25 x 16mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.During the procedure as the stent was being force to cross the lesion, the mid shaft was broke in half.A guidezilla catheter and a telescope were used to assist the stent to cross the lesion but the attempt was not successful.The device was removed intact by pulling it out.The procedure was performed with angioplasty and was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.25 x 16mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found that the distal end of the crimped stent was damaged with stent struts misaligned.The undamaged crimped stent outer diameter was measured, and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip identified damage to the distal edge of the tip.The device was received in two sections as a result of a break in the hypotube.The break was located at 25.5 cm distal to the strain relief.A visual and tactile examination found multiple kinks along both sections of the break.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15509110
• Report Number: 2124215-2022-37178
• Device Sequence Number: 5243003
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: 08714729980728
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 11/14/2022

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: 08/19/2023
• Device Model Number: H7493941816220
• Device Lot Number: 0027987701
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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: Female