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

Model Number	H7493941824300
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the non-tortuous and moderately calcified mid circumflex artery.A 3.00 x 24mm synergy xd drug-eluting stent (des) was advanced for treatment.However, during the procedure, it was noted that the balloon would not inflate and when it was disconnected, the blood flow rushed back and it was found that the middle shaft broke into 2 pieces.The entire device was removed and the procedure was completed with a 2.50 x 20mm synergy xd and a 4.00 x 16mm synergy des.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy xd mr us 3.00 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found stent damage with struts in mid to proximal region lifted and pulled distally.The undamaged stent od (outer diameter) was measured using snap gauge and was within max 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 showed signs of distal tip damage.A visual and tactile examination of the hypotube shaft found a break located at 61cm distal to the distal end of the strain relief as well as multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.Functional testing: the device was soaked overnight in a water-bath at 37 degrees.A recommended guidewire was loaded via the distal tip without issue.The returned broken distal section of the device was attached to an encore inflation device using an inflation aid.Positive pressure was applied to rated burst pressure and the balloon inflated, held pressure and deflated in 10 seconds.The stent was deployed without issue.No other issues were identified during analysis.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the non-tortuous and moderately calcified mid circumflex artery.A 3.00 x 24mm synergy xd drug-eluting stent (des) was advanced for treatment.However, during the procedure, it was noted that the balloon would not inflate and when it was disconnected, the blood flow rushed back and it was found that the middle shaft broke into 2 pieces.The entire device was removed and the procedure was completed with a 2.50 x 20mm synergy xd and a 4.00 x 16mm synergy des.There were no patient complications nor injuries reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14347857
• Report Number: 2134265-2022-04976
• Device Sequence Number: 19853074
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/06/2022

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: 12/08/2023
• Device Model Number: H7493941824300
• Device Lot Number: 0028588069
• 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: 04/25/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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 Age: 81 YR
• Patient Sex: Male