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

Model Number	H7493941812350
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 12mm synergy xd drug-eluting stent was selected for use.However, the delivery system broke after removing from the package.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 12mm synergy xd drug-eluting stent was used, however; the device broke after removing from the package.The procedure was completed with different device and no patient complications were reported.Previously, it was reported that the shaft broke.Now, it is confirmed that the tip of the hypotube was bent occurred.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 3.50 x 12mm stent delivery system was returned for analysis with a haemostatic valve attached.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured 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 tactile examination of the hypotube found multiple kinks and a break 68.6cm distal to the distal end of the strain relief.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.A kink was noted at the wire exchange port.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
H6 - device codes corrected from break 1069 to material deformation 2976.
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 12mm synergy xd drug-eluting stent was selected for use.However, the delivery system broke after removing from the package.The procedure was completed with a different device.No patient complications were reported.Previously, it was reported that the shaft broke.Now, it is confirmed that the tip of the hypotube was just bent and not fractured.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11164355
• Report Number: 2134265-2020-18891
• Device Sequence Number: 845987
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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: 09/28/2022
• Device Model Number: H7493941812350
• Device Lot Number: 0026135304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 01/12/2021; 02/02/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/29/2021; 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1