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

Catalog Number ET009533

Device Problem Difficult to Remove (1528)

Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Lot: the lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported by a healthcare professional that during a mechanical thrombectomy of a middle cerebral artery (mca) (distal m1/m2 segment) occlusion with associated cerebral infarction, the 5mm x 33mm embotrap ii revascularization device (et009533/unknown lot number) was deployed at the m2 upper trunk for the first pass, but resistance was encountered.Post-operative computed tomography (ct) imaging showed slight subarachnoid hemorrhage (sah).It was stated that the patient¿s sequelae were not affected as the bleeding was considered slight.Additional treatment, including thrombus removal, will not be provided to the patient.The physician commented that the sah was not serious because bleeding was slight, the patient¿s condition was stable, and the paralysis had improved.The patient has since been discharged from the hospital.The embotrap was allegedly used as per the instructions for use (ifu).The embotrap ii was utilized in another branch during the second pass.At that time, no resistance was felt.Recanalization was obtained.Postoperative ct showed slight sah.It was stated that the patient ¿probably¿ had bleeding at the time of the first pass.It was further mentioned that the resistance may have led to the bleeding because the patient felt resistance during traction at the m2.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received on 09-nov-2021 indicated that anonymized procedural films/images are not available for review.The physician commented that the feeling of resistance at the m2 upon device retrieval may have led to the sah.The encountered withdrawal difficulty encountered was with the vessel.The concomitant devices functioned as expected.The patient has since been discharged from the hospital.Section e1 - initial reporter phone: (b)(6).Complaint conclusion: it was reported by a healthcare professional that during a mechanical thrombectomy of a middle cerebral artery (mca) (distal m1/m2 segment) occlusion with associated cerebral infarction, the 5mm x 33mm embotrap ii revascularization device (et009533/unknown lot number) was deployed at the m2 upper trunk for the first pass, but resistance was encountered.Post-operative computed tomography (ct) imaging showed slight subarachnoid hemorrhage (sah).It was stated that the patient¿s sequelae were not affected as the bleeding was considered slight.Additional treatment, including thrombus removal, will not be provided to the patient.The physician commented that the sah was not serious because bleeding was slight, the patient¿s condition was stable, and the paralysis had improved.The patient has since been discharged from the hospital.The embotrap was allegedly used as per the instructions for use (ifu).The embotrap ii was utilized in another branch during the second pass.At that time, no resistance was felt.Recanalization was obtained.Postoperative ct showed slight sah.It was stated that the patient ¿probably¿ had bleeding at the time of the first pass.It was further mentioned that the resistance may have led to the bleeding because the patient felt resistance during traction at the m2.Additional information indicated that anonymized procedural films/images are not available for review.The physician commented that the feeling of resistance at the m2 upon device retrieval may have led to the sah.The encountered withdrawal difficulty encountered was with the vessel.The concomitant devices functioned as expected.The patient has since been discharged from the hospital.The device was discarded; therefore, no further investigation can be performed.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Withdrawal difficulty from vessel and hemorrhage secondary to vascular injury are well-known potential complications associated with the use of the embotrap ii revascularization device in mechanical thrombectomy procedures.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are patient and procedural factors including vessel characteristics, clot burden, device selection, and mechanical manipulation of devices within the artery that may have contributed to the event rather than the design or manufacture of the device.The file will be re-reviewed if additional information is received at a later date.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 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
• 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
• MDR Report Key: 12711351
• MDR Text Key: 281668842
• Report Number: 3011370111-2021-00131
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

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 Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 10/09/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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