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

Model Number	H7493941828220
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the mid left anterior descending (lad) artery.A 2.25 x 28mm synergy xd drug eluting stent was implanted for treatment.During stent implantation, proper nominal pressure was used on the stent balloon to deploy with no more than 20 seconds was used to inflate the balloon.Contrast was used in a 50:50 solution with saline in the stent balloon to be seen angiographically.The device held pressure during inflation with no evidence of a leak.The balloon was properly expanded with the use of a non-boston scientific indeflator.Complete balloon deflation was visualized under fluoroscopy before removing.However, post stent implantation, the stent balloon catheter would not come out of the body, off of the samurai wire.The physician removed all wires and devices as one unit.The procedure was completed with 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15894114
• Report Number: 2124215-2022-50118
• Device Sequence Number: 6689562
• Product Code: NIQ
• UDI-Device Identifier: 08714729980759
• UDI-Public: 08714729980759
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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: 07/23/2023
• Device Model Number: H7493941828220
• Device Lot Number: 0027788356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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