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

Model Number	H7493941828250
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since no event date provided.
Event or Problem Description
It was reported that an adverse event occurred.A 2.50 x 28mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the device failed to cross the lesion and an adverse delay occurred.No further patient complications were reported.
Event or Problem Description
It was reported that an adverse event occurred.A 2.50 x 28mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the device failed to cross the lesion and an adverse delay occurred.No further patient complications were reported.
Additional Manufacturer Narrative
B1: adverse event/product problem: updated to malfunction.B2: outcomes attrib to adv event: updated to not applicable.B3 date of event: used the first day of the month of the bsc aware date since no event date provided.H6: patient codes: updated- no clinical signs, symptoms or conditions.H6: impact code updated-no health consequence or impact.
Additional Manufacturer Narrative
B1: adverse event/product problem: updated to malfunction.B2: outcomes attrib to adv event: updated to not applicable.B3 date of event: used the first day of the month of the bsc aware date since no event date provided.B5: describe event or problem: updated.H6: patient codes: updated- no clinical signs, symptoms or conditions.H6: impact code updated-no health consequence or impact.
Event or Problem Description
It was reported that an adverse event occurred.A 2.50 x 28mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the device failed to cross the lesion and an adverse delay occurred.No further patient complications were reported.The complaint was further evaluated, and another device was able to cross the lesion to complete the procedure.The reported information does not meet criteria of a serious injury.

• 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: 12902246
• Report Number: 2134265-2021-15087
• Device Sequence Number: 4806260
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 12/16/2021

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: 03/29/2023
• Device Model Number: H7493941828250
• Device Lot Number: 0027107545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 12/08/2021; 12/08/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/14/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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; Other
• Patient Sex: Unknown