MAUDE Adverse Event Report: PHENOX LTD pRESET Delta Thrombectomy Device; Thrombus retriever

Model Number	PRE2-6 x 30
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Stroke/CVA (1770)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 5x40 was delivered to a m1 clot and upon retrieval into a sofia 88 the preset detached unintentionally, a goose neck snare was used to try to recover the stent but did not work, another 6x30 was introduced to try to deploy and retrieve the 5x40, that 6x30 also detached unintentionally.This mdr report is for the preset 6x30 device.An additional report will be submitted for the 5x40 device additional info was received on 18 may 2026: 1.Has the preset delta 6-30 been discarded by the hospital, or is it available for return and root cause analysis? only the pushers were available as they separated from the stent, and the stents were left behind in the patient.2.Following the detachment of both preset devices, were any further actions taken to remove the components from the patient's anatomy? the first step retriever detached.That's when the second one was used to try and snare and bring the first device out.Subsequently, the second device detached.Snatch were used to try and lasso the devices.But nothing was unsuccessful.3.What was the final outcome of the procedure? after both the devices detach and we're not able to be retrieved or removed.They were left, blocking the artery that was already affected by the stroke.4.What was the clinical impact on the patient, and what is their current condition? the patient was already faced with a debilitating stroke that had already completed.
Additional Manufacturer Narrative
The preset deolta stents were left behind in the patient despite attempts to remove from the artery.This further blocked the artery of the patient who was already already faced with a debilitating stroke.

• Brand Name: pRESET Delta Thrombectomy Device
• Common Device Name: Thrombus retriever
• Manufacturer (Section D): PHENOX LTD; kamrick court; ballybrit business park; galway, galway H91 X Y38; EI H91 XY38
• Manufacturer (Section G): phenox Ltd; kamrick court; ballybrit business park; galway, galway H91 X Y38; EI H91 XY38
• Manufacturer Contact: husnain ali ; kamrick court; ballybrit business park; galway, galway H91 X-Y38 ; EI H91 XY38
• MDR Report Key: 25298080
• Report Number: 3013656790-2026-00002
• Device Sequence Number: 21211584
• Product Code: NRY
• UDI-Device Identifier: 05391530910460
• UDI-Public: (01)05391530910460(17)28060510556792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K242676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PRE2-6 x 30
• Device Catalogue Number: PRE2-6 x 30
• Device Lot Number: 556792
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SOFIA 88 MICROCATHETER
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Sex: Unknown