MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309537

Device Problem Stretched (1601)

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

Event Date 12/19/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the physician, an embotrap iii 5mm x 37mm revascularization device (et309537, lot unknown) was used as a treatment for an acute ischemic stroke (ais).After the use of the embotrap, the target site was successfully recanalized without any impact on patients.When the physician checked the embotrap after being used, the stent had unraveled.It was unclear if a continuous flush was done.

Manufacturer Narrative

Product complaint # (b)(4).The device was discarded; therefore, no further investigation can be performed.A review of the dhr records for lot 21j161av confirms that there were no issues with the assembly of the lot (sub and top assembly).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: additional information received indicated that the device did not torque or rotate during advancement.There was no difficulty withdrawing the device.The system was used with the recommended microcatheter.No excessive force was applied to pull the device into the catheter for withdrawal.It is unknown how many passes were made to attempt to retrieve the clot.No additional intervention was required due to the damage.Section e1.Initial reporter phone: (b)(6).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #
=
> (b)(4) updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the physician, an embotrap iii 5mm x 37mm revascularization device ((b)(6), (b)(6)) was used as a treatment for an acute ischemic stroke (ais).After the use of the embotrap, the target site was successfully recanalized without any impact on patients.When the physician checked the embotrap after being used, the stent had unraveled.It was unclear if a continuous flush was done.This damage did not occur during treatment but was caused when a medical employee handled during removal of the stent from the microcatheter after the removal of the thrombus.It did not occur in the patient's body at the time of removal of blood clots, and therefore there was no patient injury.Additional information received indicated that the device did not torque or rotate during advancement.There was no difficulty withdrawing the device.The system was used with the recommended microcatheter.No excessive force was applied to pull the device into the catheter for withdrawal.It is unknown how many passes were made to attempt to retrieve the clot.No additional intervention was required due to the damage.The initial examination of the returned embotrap device identified the presence of a wire wound around the body sections of the device.This wire is tightly wound around body section 2 and 3, resulting in these sections and the sections adjacent to them failing to fully expand.There was also thrombus material present on the device, which may be contributing to holding the wire in place and preventing the embotrap device from fully expanding.No further damage or deformation of the device was noted.The visual inspection also indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The complaint reported that the ¿stent had unraveled¿ on the embotrap device following successful use of the embotrap device.Upon visual inspection of the embotrap device it is apparent that the embotrap device had this appearance due to an external wire from an ancillary device becoming entangled on the embotrap device.The length of wire present and the fact that all components (outer cage, inner channel, distal and proximal radiopaque coils) of the embotrap device were intact and undamaged (i.E.No fractures present), indicate that this wire is not a part of and did not originate from any part of the embotrap device.A point of contact between the wire and the embotrap was identified.The wire moved freely independently of the embotrap device outside of this point of contact, where it appears to be held in place by either a kink in the wire or the presence of dried thrombus material between the wire and the embotrap device.A review of the dhr records confirms that there were no issues with the assembly of the lot (sub and top assembly), all rejects were accounted for during the dhr review.The returned embotrap device shows no signs of visible damage or deformation other than that caused by the presence of an external wire from a separate ancillary device.The complaint event description reports that the embotrap device ¿partially unraveled¿ following successful use of the device.Based on the investigation completed and review of the complaint details the probable root cause of for the embotrap having this appearance is an interaction with an ancillary device which resulted in a wire from one of the ancillary devices being stuck in place around the embotrap device.The ancillary device used in this investigation were not specified or returned, therefore the actual root cause cannot be confirmed.Previous similar complaints concluded that such entanglement is due to ancillary device defects where wires used in the device construction impinge into the device lumen causing entanglement with devices advancing/withdrawing through that lumen.The embotrap device shows no sign of damage (other than the constraint directly related to the presence of the wire) as a result of the complaint event.The thrombectomy procedure was reported to have been successfully carried out with the returned embotrap device.There is no indication that this complaint was as 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.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: EMBOTRAP III 5 MM X 37 MM
• Type of Device: EMBOTRAP III REVASCULARIZATION DEVICE
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13204269
• MDR Text Key: 290442954
• Report Number: 3011370111-2022-00002
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: 10886704084570
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 21J161AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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