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

Model Number	H7493941824300
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	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 event date was estimated based on aware date and no date was provided.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, one of the stent struts was broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
B3 - event date: corrected from 06/01/2021 to 06/23/2021.B5.Describe event or problem- updated.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, one of the stent struts was broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.The middle struts were damaged and protruding out but all in one piece.The device was safely removed by pulling the delivery system.
Additional Manufacturer Narrative
B3 - event date: corrected from (b)(6) 2021.B5.Describe event or problem- updated.Device evaluated by mfr.: synergy xd mr us 3.00 x 24mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found evidence of damage with stent struts from the mid stent region lifted and pulled distally.The undamaged 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 microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube identified multiple kinks along the length of the hypotube shaft.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.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 target lesion was located in the left anterior descending artery.A 3.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, one of the stent struts was broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.The middle struts were damaged and protruding out but all in one piece.The device was safely removed by pulling the delivery system.

• 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: 12125923
• Report Number: 2134265-2021-08613
• Device Sequence Number: 4341893
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2021

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: 03/22/2023
• Device Model Number: H7493941824300
• Device Lot Number: 0027050797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 07/09/2021; 08/05/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/22/2021; 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1