MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 22 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309522

Device Problem Difficult to Remove (1528)

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

Event Date 04/03/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that the 49-year-old female patient with a history of hypertension, alcohol and drug use underwent a thrombectomy procedure targeting an m1 left middle cerebral artery (lmca) stroke.Right femoral artery access was made with an 8fr axs infinity ls¿ (stryker).The first pass was aspiration-only using the red 72 reperfusion catheter (penumbra).The catheter was advanced to the left internal carotid artery (lica) and a 0.024¿ aristotle® 24 guidewire (scientia vascular) and excelsior® xt-27® microcatheter (stryker) were advanced to the clot.The red 72 reperfusion catheter was advanced to the clot and aspiration turned on and the catheter pulled with no success at removing the clot form the m1 segment.The red 72 reperfusion catheter, xt-27® microcatheter, and aristotle® 24 guidewire were advanced to the left m1 area again.This time, the clot crossed again and the guidewire was removed and the 5mm x 22mm embotrap iii revascularization device (et309522/ 21g116av)was advanced and deployed.Upon retrieval after 5 minutes of deployment, resistance was felt by the physician and as he tried to remove the device, advancement of the red 72 catheter to the internal carotid artery (ica) bifurcation to help get the device removed.The red 72 catheter and embotrap iii device were removed.The physician felt that the device was too resistive and wanted it save for the cerenovus rep.A third aspiration-only pass was made and still without improvement.A solitaire retriever (medtronic) was used on the fourth pass resulting in a thrombolysis in cerebral infarction (tici) score of 2a and the procedure was stopped.It was reported that the patient condition due to the stroke was not good; as of (b)(6) 2022, it was reported that the patient has been deteriorating.It was reported that the patient had initially refused cardiac valve treatment and has a clotting problem due to drug use.On 06-apr-2022, additional information was received.The information indicated that the patient had expired.The embotrap iii device was used only for one pass as reported.Related to the clot characteristic, the fibrin clot was suspected and only fragments were removed and were not sent out for analysis.The clot was crossed with the guide wire and the excelsior xt-27 microcatheter.The embotrap iii device was retrieved under resistance and partial 20% of the device was in the 73 red aspiration catheter and removed.The pre-procedure tici score was ¿0¿ which was the reason for the procedure.A continuous flush was maintained through the microcatheter.No damage was observed on the embotrap iii device when it was removed.On 07-apr-2022, it was reported that the patient expired on (b)(6) 2022.The cause of death was brain herniation.

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The complaint product was received the product analysis lab on 20-apr-2022.The return product is pending further investigation evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.A review of the device history records (dhr) confirms that there were no issues with the assembly of the lot 21g116av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that the 49-year-old female patient with a history of hypertension, alcohol and drug use underwent a thrombectomy procedure targeting an m1 left middle cerebral artery (lmca) stroke.Right femoral artery access was made with an 8fr axs infinity ls¿ (stryker).The first pass was aspiration-only using the red 72 reperfusion catheter (penumbra).The catheter was advanced to the left internal carotid artery (lica) and a 0.024¿ aristotle® 24 guidewire (scientia vascular) and excelsior® xt-27® microcatheter (stryker) were advanced to the clot.The red 72 reperfusion catheter was advanced to the clot and aspiration turned on and the catheter pulled with no success at removing the clot form the m1 segment.The red 72 reperfusion catheter, xt-27® microcatheter, and aristotle® 24 guidewire were advanced to the left m1 area again.This time, the clot crossed again and the guidewire was removed and the 5mm x 22mm embotrap iii revascularization device (et309522/ 21g116av)was advanced and deployed.Upon retrieval after 5 minutes of deployment, resistance was felt by the physician and as he tried to remove the device, advancement of the red 72 catheter to the internal carotid artery (ica) bifurcation to help get the device removed.The red 72 catheter and embotrap iii device were removed.The physician felt that the device was too resistive and wanted it save for the cerenovus rep.A third aspiration-only pass was made and still without improvement.A solitaire retriever (medtronic) was used on the fourth pass resulting in a thrombolysis in cerebral infarction (tici) score of 2a and the procedure was stopped.It was reported that the patient condition due to the stroke was not good; as of 04 apr 2022, it was reported that the patient has been deteriorating.It was reported that the patient had initially refused cardiac valve treatment and has a clotting problem due to drug use.On 06-apr-2022, additional information was received.The information indicated that the patient had expired.The embotrap iii device was used only for one pass as reported.Related to the clot characteristic, the fibrin clot was suspected and only fragments were removed and were not sent out for analysis.The clot was crossed with the guide wire and the excelsior xt-27 microcatheter.The embotrap iii device was retrieved under resistance and partial 20% of the device was in the 73 red aspiration catheter and removed.The pre-procedure tici score was ¿0¿ which was the reason for the procedure.A continuous flush was maintained through the microcatheter.No damage was observed on the embotrap iii device when it was removed.On 07-apr-2022, it was reported that the patient expired on (b)(6) 2022.The cause of death was brain herniation.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the initial examination of the returned embotrap device identified no visible evidence of deformation or damage to the device.All radiopaque markers and coils were confirmed as present and undamaged.The visual inspection also indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints fully intact and undamaged.The returned embotrap device was successfully passed through a 0.0195-inch id tube, confirming that the profile conformed to the specification for compatibility with 0.021-inch microcatheters.A clot retrieval was carried out with the returned device in an attempt to recreate the complaint event under conditions consistent with those described in the complaint event description.The returned device was successfully delivered through a sample excelsior xt-27 microcatheter and deployed within the fibrin rich clot.Clot engagement was achieved, where the device successfully deployed within the clot, flow restoration was visually observed and the returned embotrap device successfully retrieved a fibrin rich clot to the aspiration catheter tip.No resistance or high forces were experienced during clot retrieval.This indicates that the returned embotrap device is capable of correct clot engagement and smooth clot retrieval without resistance.It is probable that other patient or case specific factors (clot composition, vessel condition) may have contributed to the resistance experienced during the complaint event.A review of the device history records (dhr) confirms that there were no issues with the assembly of the lot 21g116av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Investigation conclusion: the returned embotrap device shows no evidence of damage or deformation with all design features present and undamaged.The returned embotrap device was successfully passed through a 0.0195-inch id tube confirming that the profile conformed to the specification for compatibility with 0.021-inch microcatheters.The returned embotrap device was successfully delivered through a sample excelsior xt-27 microcatheter, successfully engaged with, and retrieved a fibrin rich clot.No resistance or high forces were experienced during clot retrieval with the returned embotrap device.The complaint event could not be confirmed.The complaint report stated that it was suspected that a fibrin rich clot was present as the embotrap and additional stent retriever experienced difficulty during retrieval.As the returned device shows no evidence of damage or deformation, and successfully retrieved clot under test conditions, it can be concluded that the most likely cause of resistance during retrieval during the complaint event are case and/or patient specific factors such as vessel tortuosity.There is no indication that this complaint was as a result of a defect with the embotrap device.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.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: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14176681
• MDR Text Key: 299044495
• Report Number: 3011370111-2022-00034
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• 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: 21G116AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• 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
• Treatment: ARISTOTLE® 24 GUIDEWIRE (SCIENTIA VASCULAR); AXS INFINITY LS¿ (STRYKER); EXCELSIOR® XT-27® MICROCATHETER (STRYKER); RED 72 REPERFUSION CATHETER (PENUMBRA)
• Patient Age: 49 YR
• Patient Sex: Female