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

Model Number	H7493941816220
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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 no evidence of any damage.The crimped stent od (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 showed no signs of damage.The device was received in two sections as a result of a break in the hypotube.The break was located at 73.5cm distal to the distal end of the strain relief.A visual and tactile examination of the hypotube found multiple kinks along both sections.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The device was soaked overnight in the waterbath.The device was later tracked over a 0.014 inch wire with no resistance.As part of the functional testing an encore inflation device was attached to the broken hypotube shaft and the device was inflated using an encore to its rated burst pressure of 18 atmospheres with no leaks noted.Using the same encore, a vacuum was pulled and the balloon deflated fully with no resistance noted.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 15nov2021.It was reported that balloon leak occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified proximal left anterior descending artery.A 2.25 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon would not inflate properly and hold pressure.The procedure was completed with another of same device.There were no patient complications.However, returned device analysis revealed a hypotube separation.

• 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: 12857813
• Report Number: 2134265-2021-14705
• Device Sequence Number: 12050984
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: 08714729980728
• 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): 11/22/2021

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: 02/24/2023
• Device Model Number: H7493941816220
• Device Lot Number: 0026924659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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: Unknown