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

Model Number	H7493941816220
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.25 x 16mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube found multiple links along the hypotube.A visual and microscopic examination identified a partial fracture, 34.6cm proximal from the tip, at the lasercut region.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and a tactile examination was performed.No issues were noted.An attempt was made to inflate the balloon using an encore inflation unit.The balloon failed to inflate due to liquid leaking out through the partial fracture at the lasercut region.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 26jan2022.It was reported that the balloon inflation failure occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified diagonal branch.A 2.25 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during inflation, the balloon would not inflate.The stent was removed and the it was noticed that there was blood in the inflator.The procedure was completed with a 2.25x12mm synergy xd drug-eluting stent.No patient complications were reported.However, returned device analysis revealed a partial fracture of the shaft.

• 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: 13471995
• Report Number: 2134265-2022-00928
• Device Sequence Number: 20006314
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: 08714729980728
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 02/07/2022

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: 06/21/2023
• Device Model Number: H7493941816220
• Device Lot Number: 0027590215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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