MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK?-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M001363830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Ischemia (1942); Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced blood flow obstruction associated with venous thrombosis requiring additional intervention.A 20mm x 40cm interlock.035 coil was successfully implanted on (b)(6) 2026 to treat pelvic varicose veins.During a follow-up visit on (b)(6) 2025, the patient reported swelling and pain in the left lower limb, prompting further evaluation.An angiogram revealed that the implanted coil was causing blood flow obstruction associated with venous thrombosis.There were no signs of coil displacement, and the device remained in the correct target location at the time the obstruction was identified.Thromboaspiration was performed.A second procedure was then performed for percutaneous coil removal and a new thrombectomy procedure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.D6b: explant date: updated.Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the interlock.035 device confirmed that the reported events are known events defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that the patient experienced blood flow obstruction associated with venous thrombosis requiring additional intervention.A 20mm x 40cm interlock.035 coil was successfully implanted on (b)(6) 2026 to treat pelvic varicose veins.During a follow-up visit on (b)(6) 2025, the patient reported swelling and pain in the left lower limb, prompting further evaluation.An angiogram revealed that the implanted coil was causing blood flow obstruction associated with venous thrombosis.There were no signs of coil displacement, and the device remained in the correct target location at the time the obstruction was identified.Thromboaspiration was performed.A second procedure was then performed for percutaneous coil removal and a new thrombectomy procedure.It was further reported that the anatomical location where the thrombosis was observed was located in the common femoral vein extending to the popliteal vein.The coil was deployed in the iliac vein.On (b)(6) 2026, an intervention was performed in which a percutaneous removal of the coils and a new thrombectomy were carried out.Subsequently, the patient consulted again on (b)(6) 2026 due to edema.

• Brand Name: INTERLOCK?-35
• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24460805
• Report Number: 2124215-2026-10832
• Device Sequence Number: 10052451
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: (01)08714729795445
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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 Model Number: M001363830
• Device Catalogue Number: M001363830
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/02/2026
• 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 Age: 36 YR
• Patient Sex: Female