MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number ET009533

Device Problems Difficult to Remove (1528); Premature Separation (4045)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).[conclusion]: the healthcare professional reported that during a mechanical thrombectomy procedure of a middle cerebral artery (mca) m1 segment occlusion, the 5mm x 33mm embotrap ii revascularization device (et009533 / 20d088av) was used with the phenom¿ 27 microcatheter (medtronic) and the react¿ aspiration catheter (medtronic) for a second pass but the force required to retract the device from the patient and the junction between the cage and the delivery wire became separated.The patient experienced a mild subarachnoid hemorrhage (sah) at the target lesion and the blood vessels remain open.There was no information provided to indicate that the patient¿s condition has worsen as a result of the event.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (20d088av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Withdrawal difficulty, device detachment, and hemorrhage are known potential procedural complications associated with the embotrap ii revascularization device.The embotrap instructions for use (ifu) warns the user to never withdraw the device against significant resistance.Assess the cause of resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.With the amount of information available and without films of the event, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical and procedural factors, including vessel characteristics, tortuosity, clot burden, device interaction, device selection, and operator technique, that may have contributed to the event rather than the design or manufacture of the device.There was no report of vessel injury or trauma that may have been a source of the hemorrhage.The alleged withdrawal difficulty with device detachment ultimately led to the cage assembly being left in the patient¿s mca with significant risk for embolization, ischemia, or infarct, and / or the need for additional intervention and lifelong anticoagulation / antiplatelet therapy.Moreover, the patient suffered from a mild sah at the target site.Therefore, the event meets mdr reporting criteria as a ¿serious injury.¿ with the limited information available and without the complaint product available for analysis, the reported device issues cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during a mechanical thrombectomy procedure of a middle cerebral artery (mca) m1 segment occlusion, the 5mm x 33mm embotrap ii revascularization device (et009533 / 20d088av) was used with the phenom¿ 27 microcatheter (medtronic) and the react¿ aspiration catheter (medtronic) for a second pass but the force required to retract the device from the patient and the junction between the cage and the delivery wire became separated.The patient experienced a mild subarachnoid hemorrhage (sah) at the target lesion and the blood vessels remain open.There was no information provided to indicate that the patient¿s condition has worsen as a result of the event.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 12/21/2020.[additional event information]: the healthcare professional reported that during a mechanical thrombectomy procedure of a middle cerebral artery (mca) m1 segment occlusion, the 5mm x 33mm embotrap ii revascularization device (et009533 / 20d088av) was used with the phenom¿ 27 microcatheter (medtronic) and the react¿ aspiration catheter (medtronic) for a second pass but the force required to retract the device from the patient and the junction between the cage and the delivery wire became separated.The patient experienced a mild subarachnoid hemorrhage (sah) at the target lesion and the blood vessels remain open.There was no information provided to indicate that the patient¿s condition has worsen as a result of the event.Additional information received confirmed that the target lesion / occlusion was the m1 segment.However, no further information was available.E.1: the initial reporter phone: (b)(6).The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 10969307
• MDR Text Key: 220245796
• Report Number: 3011370111-2020-00089
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20D088AV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHENOM¿ 27 MICROCATHETER (MEDTRONIC); REACT¿ ASPIRATION CATHETER (MEDTRONIC); PHENOM¿ 27 MICROCATHETER (MEDTRONIC); REACT¿ ASPIRATION CATHETER (MEDTRONIC)
• Patient Outcome(s): Life Threatening