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

Model Number	H7493941838400
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on balloon occurred.The target lesion was located in the mildly tortuous mid circumflex artery.A 4.00 x 38mm synergy xd drug-eluting stent (des) was advanced to treat the lesion.However, during the procedure, the device failed to cross the lesion, and the physician noticed that the stent appeared to be partially detached from the balloon.The stent was carefully removed back into the guide and withdrawn.The procedure was completed with another synergy xd des.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr us 4.00 x 38 mm stent delivery system (sds); catheter was returned for analysis; the following attributes were examined: stent: examination of the crimped stent via scope found evidence of damage with stent struts from the mid to distal stent region lifted and pulled distally over the tip.The undamaged crimped stent od (outer diameter) was measured within max crimped stent profile measurement specification.Balloon: 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.Tip profile: a visual and microscopic examination of the bumper tip no issues.Hypotube profile: a visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent moved on balloon occurred.The target lesion was located in the mildly tortuous mid circumflex artery.A 4.00 x 38mm synergy xd drug-eluting stent (des) was advanced to treat the lesion.However, during the procedure, the device failed to cross the lesion, and the physician noticed that the stent appeared to be partially detached from the balloon.The stent was carefully removed back into the guide and withdrawn.The procedure was completed with another synergy xd des.No patient complications were 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15788635
• Report Number: 2124215-2022-46730
• Device Sequence Number: 5578707
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: 08714729981176
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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
• Report Date (Section B): 12/12/2022

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: 03/21/2024
• Device Model Number: H7493941838400
• Device Lot Number: 0029125090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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