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

Model Number	H7493941824350
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in non-tortuous and moderate to severely calcified right coronary artery.Following pre-dilatation, a 3.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion.The device was removed from the patient and upon inspection of the stent, it appeared buckled in the center.The actual mid stent strut appeared like it was caught on something.The procedure was completed with different device.There were no patient complications reported.
Additional Manufacturer Narrative
Correction: h6 device codes: failure to advance (a150204) initially reported and has now updated to difficult to advance (a150205) device evaluated by mfr.: synergy xd mr us 3.50 x 24mm mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found evidence of damage with stent struts from the proximal to mid stent region lifted, pulled, and bunched 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 tactile examination of the hypotube identified multiple kinks along the length of the hypotube shaft.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 tactile examination.No issues were noted.The device was loaded without issues on a test guidewire.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 non-tortuous and moderate to severely calcified right coronary artery.Following pre-dilatation, a 3.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion.The device was removed from the patient and upon inspection of the stent, it appeared buckled in the center.The actual mid stent strut appeared like it was caught on something.The procedure was completed with different device.There were no patient complications reported.

• 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: 12187507
• Report Number: 2134265-2021-09179
• Device Sequence Number: 17021468
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: 08714729981060
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/12/2021

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: 04/07/2023
• Device Model Number: H7493941824350
• Device Lot Number: 0027168674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1