MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M001361530
Medical Device Problem Codes	Break (1069); Stretched (1601); Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Codes	Nerve Damage (1979); Foreign Body In Patient (2687)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil arm detached and migrated into the cerebellum.The non-stenosed target lesion was located in the severely tortuous and non-calcified right internal thoracic artery.A 4mm x 15cm interlock was selected for collateral embolism of the internal thoracic artery after a graen's procedure and before a fontan procedure.A total of 12 embolic coils were placed in the internal thoracic artery.However, it was observed that the 9th coil was protruding.A snare was used to grasp the 9th coil.It was grasped approximately 1cm from the interlocking arm with the snare and pulled.However, the coil unraveled and broke off at the part where it was snared.The detached component migrated into the cerebral blood vessels and deep into the cerebellum.A neurosurgeon determined that it could not be retrieved.Subsequent ct and mri scans have determined that it is impossible to retrieve the detached arm.The unraveled part of the coil that remained in the internal thoracic artery was retrieved by a surgeon through thoracotomy.The phrenic nerve was damaged when the coil was surgically retrieved, which caused some diaphragm problems.There were no further signs of an impact on the overall patient condition.
Event or Problem Description
It was reported that the coil arm detached and migrated into the cerebellum.The non-stenosed target lesion was located in the severely tortuous and non-calcified right internal thoracic artery.A 4mm x 15cm interlock was selected for collateral embolism of the internal thoracic artery after a graen's procedure and before a fontan procedure.A total of 12 embolic coils were placed in the internal thoracic artery.However, it was observed that the 9th coil was protruding.A snare was used to grasp the 9th coil.It was grasped approximately 1cm from the interlocking arm with the snare and pulled.However, the coil unraveled and broke off at the part where it was snared.The detached component migrated into the cerebral blood vessels and deep into the cerebellum.A neurosurgeon determined that it could not be retrieved.Subsequent ct and mri scans have determined that it is impossible to retrieve the detached arm.The unraveled part of the coil that remained in the internal thoracic artery was retrieved by a surgeon through thoracotomy.The phrenic nerve was damaged when the coil was surgically retrieved, which caused some diaphragm problems.There were no further signs of an impact on the overall patient condition.It was further reported that a balloon catheter to try to push coil into internal thoracic artery but that also did not work.The maneuvers would move orientation of protruding portion of coil temporarily, but it would then return to where it was.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20904232
• Report Number: 2124215-2024-74530
• Device Sequence Number: 17136079
• Product Code: KRD
• UDI-Device Identifier: 08714729764960
• UDI-Public: 08714729764960
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 07/31/2025
• Device Model Number: M001361530
• Device Catalogue Number: M001361530
• Device Lot Number: 0030062519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 08/31/2022
• 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 Age: 12 MO
• Patient Sex: Female