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

Model Number	H7493941828350
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device entrapment and shaft break occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified mid left anterior descending artery.A 3.50 x 28mm synergy xd drug-eluting stent was advanced for treatment; however, during the procedure, the stent delivery catheter became stuck in the vessel.When the physician attempted to push and pull the device, the shaft broke in the aorta at approximately 100 cm from the hub, leaving the distal shaft and stent all intact but in the body.The vessel was wired with a separate wire and delivered a balloon distal to the broken off stent shaft, inflated slightly and pulled everything out at once.The procedure was completed with another 3.50 x 28mm synergy xd stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 3.50 x 28mm stent delivery system was returned for analysis.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 diamteter 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 signs of distal tip damage.A visual and tactile examination of the hypotube identified a break on the hypotube shaft located at 40.5 cm distal to the distal end of strain relief as well as multiple kinks.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment and shaft break occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified mid left anterior descending artery.A 3.50 x 28mm synergy xd drug-eluting stent was advanced for treatment; however, during the procedure, the stent delivery catheter became stuck in the vessel.When the physician attempted to push and pull the device, the shaft broke in the aorta at approximately 100 cm from the hub, leaving the distal shaft and stent all intact but in the body.The vessel was wired with a separate wire and delivered a balloon distal to the broken off stent shaft, inflated slightly and pulled everything out at once.The procedure was completed with another 3.50 x 28mm synergy xd stent.There were no patient complications reported.

• 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: 12648457
• Report Number: 2134265-2021-13007
• Device Sequence Number: 1416667
• Product Code: NIQ
• UDI-Device Identifier: 08714729981077
• UDI-Public: 08714729981077
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 11/29/2021

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: 02/17/2023
• Device Model Number: H7493941828350
• Device Lot Number: 0026902684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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