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

Model Number	H7493941828250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 28mm synergy xd drug eluting stent was used for treatment.However, it was noted that the shaft of the stent broke.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 28mm synergy xd drug eluting stent was used for treatment.However, it was noted that the shaft of the stent broke.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.50 x 28mm stent delivery system (sds) 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 by snap gauge and the result was 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 kinks and a break 3.4 cm distal to the distal end of the strain relief.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.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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12590729
• Report Number: 2134265-2021-12571
• Device Sequence Number: 12702551
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: 04/22/2023
• Device Model Number: H7493941828250
• Device Lot Number: 0027262394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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