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

Model Number	H7493941816270
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	08/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The patient presented with coronary artery disease (cad).The target lesion was located in the coronary artery.A 2.75 x 16mm synergy xd drug eluting stent was advanced for treatment.However, stent fold while trying to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that stent damage occurred.The patient presented with coronary artery disease (cad).The target lesion was located in the coronary artery.A 2.75 x 16mm synergy xd drug eluting stent was advanced for treatment.However, stent fold while trying to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that during the procedure, the stent failed to cross the lesion and the stent strut was lifted.
Additional Manufacturer Narrative
Device evaluation by mfr: synergy xd mr us 2.75 x 16mm stent delivery system (sds).Examination of the crimped stent via scope found evidence of damage with stent struts from the proximal stent region lifted.The undamaged crimped stent od (outer diameter) was measured by snap gauge and the result was 0.0380" this is 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.Examination of the tip via scope found no damage to the tip.A visual and tactile examination of the hypotube identified a break on the hypotube shaft located at 65cm distal to the distal end of strain relief as well as multiple kinks.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination and no issues were noted.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The patient presented with coronary artery disease (cad).The target lesion was located in the coronary artery.A 2.75 x 16mm synergy xd drug eluting stent was advanced for treatment.However, stent fold while trying to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that during the procedure, the stent failed to cross the lesion and the stent strut was lifted.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12405526
• Report Number: 2134265-2021-11070
• Device Sequence Number: 17238605
• Product Code: NIQ
• UDI-Device Identifier: 08714729980889
• UDI-Public: 08714729980889
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2021

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: 02/24/2023
• Device Model Number: H7493941816270
• Device Lot Number: 0026941868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 09/02/2021; 10/12/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/16/2021; 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1