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

Model Number	H7493941838400
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an adverse patient event occurred.A 4.00 x 38mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.The inability to cross the lesion caused a significant delay to the procedure that resulted in an adverse patient event.Despite multiple efforts, no further information was able to be obtained.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 38 mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found evidence of damage with proximal and mid stent struts noted to be lifted and pulled distally.The undamaged crimped stent outer diameter was measured by snap gauge 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 no signs of tip damage.A visual and tactile examination of the hypotube identified multiple kinks along the length of the shaft.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and a tactile examination was performed.No issues were noted.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that an adverse patient event occurred.A 4.00 x 38mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.The inability to cross the lesion caused a significant delay to the procedure that resulted in an adverse patient event.Despite multiple efforts, no further information was able to be obtained.

• 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: 14649308
• Report Number: 2134265-2022-06632
• Device Sequence Number: 11740886
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: 08714729981176
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: H7493941838400
• Device Lot Number: 0028259163
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown