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

Model Number	H7493941816400
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgment occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery.After a 6f non-boston scientific guide catheter was placed, a 4.00 x 16mm synergy xd drug-eluting stent was introduced but there was difficulty advancing, even with the haemostatic valve fully open.When the delivery system was removed, the stent remained floating in the artery.The entire delivery system, wire and guide were all removed but the stent remained in the patient.The procedure was completed with a different device.There were no patient complications.
Additional Manufacturer Narrative
B5 describe event or problem, h6 patient codes, and h6 device codes: corrected.
Event or Problem Description
It was reported that stent dislodgment occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery.After a 6f non-boston scientific guide catheter was placed, a 4.00 x 16mm synergy xd drug-eluting stent was introduced but there was difficulty advancing, even with the haemostatic valve fully open.When the delivery system was removed, the stent remained floating in the artery.The entire delivery system, wire and guide were all removed but the stent remained in the patient.The procedure was completed with a different device.There were no patient complications.It was further reported that there were two synergy xd stents involved in the procedure and that the 4.00 x 16mm stent did not become dislodged.The 4.00 x 16mm stent could not advance and the stent became damaged.The 4.00 x 24mm synergy xd stent dislodged inside the patient and was crushed against the vessel wall with another stent.The patient was doing well post-procedure.
Additional Manufacturer Narrative
The synergy xd mr us 4.00 x 16mm stent delivery system was returned for analysis.A visual examination of the stent found that the struts in both the proximal and distal ends were found to be lifted from their crimped position.The stent was found to be moved proximally along the balloon material.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed tip damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A 0.014 test guidewire loaded successfully.No issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgment occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery.After a 6f non-boston scientific guide catheter was placed, a 4.00 x 16mm synergy xd drug-eluting stent was introduced but there was difficulty advancing, even with the haemostatic valve fully open.When the delivery system was removed, the stent remained floating in the artery.The entire delivery system, wire and guide were all removed but the stent remained in the patient.The procedure was completed with a different device.There were no patient complications.It was further reported that there were two synergy xd stents involved in the procedure and that the 4.00 x 16mm stent did not become dislodged.The 4.00 x 16mm stent could not advance and the stent became damaged.The 4.00 x 24mm synergy xd stent dislodged inside the patient and was crushed against the vessel wall with another stent.The patient was doing well post-procedure.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12771160
• Report Number: 2134265-2021-13307
• Device Sequence Number: 19888026
• Product Code: NIQ
• UDI-Device Identifier: 08714729981121
• UDI-Public: 08714729981121
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2023
• Device Model Number: H7493941816400
• Device Lot Number: 0026588298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021; 12/03/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/29/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 6F CORDIS; GUIDE CATHETER: 6F CORDIS; GUIDE CATHETER: 6F CORDIS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown