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

Model Number	H7493941820300
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the proximal left anterior descending artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced to treat the lesion.However, it was noticed that the stent dislodged from the balloon.Snaring was attempted but the stent was unable to be retrieved.The physician then deployed another 3.00 x 20mm synergy xd stent and pushed the dislodged stent up against the vessel.The procedure was completed and no patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the proximal left anterior descending artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced to treat the lesion.However, it was noticed that the stent dislodged from the balloon.Snaring was attempted but the stent was unable to be retrieved.The physician then deployed another 3.00 x 20mm synergy xd stent and pushed the dislodged stent up against the vessel.The procedure was completed and no patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy xd mr us 3.00 x 16mm stent delivery system (sds) was returned for analysis without the stent.The device was returned without the stent.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was 0.041 inches.This is within max crimped stent profile measurement.The balloon was reviewed, and it appeared to be in a deflated state with signs of positive pressure being applied to its cones noted.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found no issues with the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12620559
• Report Number: 2134265-2021-12672
• Device Sequence Number: 11064160
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: 08714729980971
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 11/18/2021

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: 05/18/2023
• Device Model Number: H7493941820300
• Device Lot Number: 0027418752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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: Required Intervention
• Patient Sex: Unknown