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

Model Number	H7493941812270
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 2.75 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the stent was damaged while trying to cross the lesion.The procedure was completed with a different device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that stent damage occurred.A 2.75 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the stent was damaged while trying to cross the lesion.The procedure was completed with a different device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 2.75 x 12mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage noted in the proximal through to the mid section.Struts were found to be lifted from their crimped position and bunched.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.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: 12524178
• Report Number: 2134265-2021-11997
• Device Sequence Number: 17289164
• Product Code: NIQ
• UDI-Device Identifier: 08714729980872
• UDI-Public: 08714729980872
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• 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: 02/02/2023
• Device Model Number: H7493941812270
• Device Lot Number: 0026835172
• 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): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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