MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 22 MM; CATHETER, THROMBUS RETRIEVER

Model Number ET309522

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Section h.3: the product was received in the product analysis lab on 26-may-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.A review of the manufacturing documentation associated with this lot (22l202av) 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.

Event Description

The healthcare professional reported that during a thrombectomy procedure to treat an ischemic stroke in a 92-year-old female patient, the 5mm x 22mm embotrap iii revascularization device (et309522 / 22l202av) was delivered to the m2 segment of the middle cerebral artery (mca) via a prowler ex microcatheter (mc2165s2u / 30989723).It was reported by a staff member that the physician felt resistance when removing the embotrap iii device.The embotrap iii device and the prowler ex microcatheter were removed from the vessel.After removal, damage to the distal end of the prowler ex microcatheter was noticed.There was also damage to the distal end of the embotrap iii device.¿it appeared that the distal end of the embotrap folded back on itself.¿ other devices were used to complete the procedure.There was no fragments generated from the devices.The procedure was not delayed due to the reported event.There was no negative patient impact.The prowler ex microcatheter is not available for return.On 26-may-2023, additional information was received.The information indicated that the clot characteristics and vessel tortuosity are not known.One pass was made with the embotrap iii and the prowler ex microcatheter; resistance was encountered at removal of this one pass.Continuous flush had been maintained through the prowler ex microcatheter.There was no evidence of thromboembolism due to the reported withdrawal difficulty.It cannot be confirmed if inadvertent force had been exerted on the device when the resistance was encountered.The specific details on the damage noted on the prowler ex microcatheter are not known.The reported issue resulted in no delays of any significance.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: the initial examination, and further examination under magnification of the returned embotrap device showed evidence of damage to the distal coil assembly of the device.The distal coil was entangled in the floating crown of the body segment.This caused the distal segment of the device to be folded back on itself.The visual inspection also concluded that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The returned embotrap device could not be successfully passed through a 0.0195-inch id tube when the device was entangled at the distal end.The entanglement of the device was resolved using a tweezers and the only deformation remaining on the device was the damage to the distal coil.The untangled returned embotrap device could be successfully passed through a 0.0195-inch id tube, confirming that the profile conformed to the specification for compatibility with 0.021-inch microcatheters.Device insertion and delivery assessments were performed using the untangled returned embotrap device and a sample prowler ex microcatheter on the benchtop.The returned embotrap device was successfully delivered to the distal tip of the sample prowler ex microcatheter without issue.Recreation attempts of device entanglement were performed in the e062-03 silicone vascular model using the returned embotrap device and a sample prowler ex microcatheter.When deployed at a vessel wall, the returned embotrap device became tangled in a similar way to the observed complaint unit prior to untangling.Further recreation attempts of device entanglement were performed on a sample embotrap device and a sample prowler ex microcatheter.Despite repeated attempts, the distal coil did not become entangled in the device, however damage to the distal coil was observed.An evaluation on the resistance during withdrawal of the returned tangled embotrap was performed using a sample prowler ex microcatheter.It was confirmed that firm resistance was felt which prevented retraction of the returned embotrap device through the prowler ex microcatheter.Visual inspection of the sample prowler ex post-evaluation showed evidence of damage and deformation to the distal tip, caused by the tangled returned embotrap device.The complaint event was confirmed.A review of the manufacturing documentation associated with this lot (22l202av) 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.Investigation conclusion: the returned embotrap device showed signs of damage and deformation.A visual examination of the microcatheter or other ancillary devices used during the complaint event was not possible as none were returned for examination.Recreation attempts of device entanglement were performed on the returned embotrap device and a sample embotrap device, with a sample prowler ex microcatheter.It was observed that device entanglement occurred on the returned embotrap device but not on the sample embotrap device.Minor deformation to the distal coil was caused by repeated deployments at a vessel wall.It was concluded that minor damage to the distal coil through deployment against the vessel wall may lead to device entanglement.An evaluation of the resistance on withdrawal through a sample prowler ex microcatheter was performed with the returned embotrap device.Firm resistance prevented full retraction of the returned embotrap device and visual inspection of the microcatheter post-use showed evidence of damage and deformation, thus confirming the complaint event.It was reported that the prowler ex microcatheter used in the procedure was damaged at the distal tip.The potential cause for the damage is retraction of the entangled embotrap device through the microcatheter.The assignable cause to the damage on the distal coil of the embotrap device and subsequent entanglement could not be confirmed.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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 III 5 MM X 22 MM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17027914
• MDR Text Key: 317467345
• Report Number: 3011370111-2023-00057
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082866
• UDI-Public: 10886704082866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309522
• Device Catalogue Number: ET309522
• Device Lot Number: 22L202AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 160CM 5CM DISTAL 2 MB STR TIP.
• Patient Age: 92 YR
• Patient Sex: Female