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

Model Number	H7493941838300
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.00 x 38mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts on the proximal and distal end were flared.The undamaged stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.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.
Event or Problem Description
Reportable based on device analysis completed on 03-feb 2022.It was reported that balloon damage occurred.A 3.00 x 38mm synergy xd drug-eluting stent was selected for use.However, prior to load the device into the wire, it was noticed that the balloon was slightly inflated and not fully wrapped.It was also noted that there was accidental pressure applied to the balloon during preparation.A new stent was opened and the procedure was completed with another of same device.There were no patient complications reported.However, returned device analysis revealed stent damage.

• 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: 13595350
• Report Number: 2134265-2022-01222
• Device Sequence Number: 16627019
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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
• Report Date (Section B): 02/24/2022

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: 09/28/2023
• Device Model Number: H7493941838300
• Device Lot Number: 0028183124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• 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
• Patient Sex: Unknown