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

Catalog Number ET009533

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Vascular Dissection (3160)

Event Date 07/07/2021

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product lot number was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report from the field indicated that the patient with a history of kidney failure (on dialysis) underwent mechanical thrombectomy of a neurovascular occlusion with a 5mm x 33mm embotrap ii (et009533/unknown lot number) revascularization device and suffered from an intraoperative subarachnoid hemorrhage (sah).The patient expired later that evening.It was stated that the patient was on dialysis and in poor condition.Three passes were made with the embotrap device, and the clot was able to be retrieved during the third pass.Recanalization was achieved; however, the patient ultimately expired.It was further reported that the white thrombus was difficult to ¿get entangled¿ and the faint sah may have occurred because the blood vessel was slightly pulled.Additional information received on 12 jul 2021 confirmed that the date of the procedure and date of the death were (b)(6) 2021.Additional information received on 15 jul 2021 indicated that a 200cm chikai (asahi intecc) guidewire, a 90cm optimo (tokai medical) balloon guide catheter, an 0.027¿ marksman (medtronic) microcatheter, and an ace68 (penumbra) aspiration catheter were used as concomitant devices.Additional information received on 21 jul 2021 indicated that the target occlusion was located at the distal m1 segment of the middle cerebral artery (mca).The region for deployment was the distal m2 segment of the mca.After the first pass made with the embotrap ii, dissection and hemorrhage were confirmed at the site of the obstruction.A transform (stryker) balloon catheter was inflated to stop the bleeding.The embotrap ii was used again but the same issue occurred.This process was repeated and a total of three passes were implemented.Finally, the procedure was completed after confirming that there was no bleeding.No additional treatment was performed.The patient ultimately expired.¿although it was not mentioned as serious, there was a suggestion that intraoperative bleeding, etc.Might be related to the use of the stent with the deployed position elevated to m2d.¿ this adverse event was considered related to the complaint device.No further information was provided.

Manufacturer Narrative

Product complaint#: (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 25 aug 2021 indicated that the treating physician initially reported incorrect information to the sales representative regarding the patient condition and procedural sequence.The reported bleeding did not occur intraoperatively.The hemorrhage was noted on post-operative computed tomography (ct) imaging.No further treatment was provided to the patient, and the patient ultimately expired that night.The embotrap ii device was deployed at the distal m2 segment of the mca.The embotrap ii device was reportedly used as per the instructions for use (ifu).Upon further review, the customer concluded that the fatal hemorrhage was not related to the use of the embotrap as the device was used according to the ifu guidelines.There was no intraoperative bleeding that was attributed to the use of the device.Complaint conclusion: a report from the field indicated that the patient with a history of kidney failure (on dialysis) underwent mechanical thrombectomy of a neurovascular occlusion with a 5mm x 33mm embotrap ii (et009533/unknown lot number) revascularization device and suffered from an intraoperative subarachnoid hemorrhage (sah).The patient expired later that evening.It was stated that the patient was on dialysis and in poor condition.Three passes were made with the embotrap device, and the clot was able to be retrieved during the third pass.Recanalization was achieved; however, the patient ultimately expired.It was further reported that the white thrombus was difficult to ¿get entangled¿ and the faint sah may have occurred because the blood vessel was slightly pulled.The complaint device is not available for evaluation.Additional information received on 12 jul 2021 confirmed that the date of the procedure and date of the death were on (b)(6) 2021.Additional information received on 15 jul 2021 indicated that a 200cm chikai (asahi intecc) guidewire, a 90cm optimo (tokai medical) balloon guide catheter, an 0.027¿ marksman (medtronic) microcatheter, and an ace68 (penumbra) aspiration catheter were used as concomitant devices.Additional information received on 21 jul 2021 indicated that the target occlusion was located at the distal m1 segment of the middle cerebral artery (mca).The region for deployment was the distal m2 segment of the mca.After the first pass made with the embotrap ii, dissection and hemorrhage were confirmed at the site of the obstruction.A transform (stryker) balloon catheter was inflated to stop the bleeding.The embotrap ii was used again but the same issue occurred.This process was repeated and a total of three passes were implemented.Finally, the procedure was completed after confirming that there was no bleeding.No additional treatment was performed.The patient ultimately expired.¿although it was not mentioned as serious, there was a suggestion that intraoperative bleeding, etc.Might be related to the use of the stent with the deployed position elevated to m2d.¿ this adverse event was considered related to the complaint device.Additional information received on 25 aug 2021 indicated that the treating physician initially reported incorrect information to the sales representative regarding the patient condition and procedural sequence.The reported bleeding did not occur intraoperatively.The hemorrhage was noted on post-operative computed tomography (ct) imaging.No further treatment was provided to the patient, and the patient ultimately expired that night.The embotrap ii device was deployed at the distal m2 segment of the mca.The embotrap ii device was reportedly used as per the instructions for use (ifu).Upon further review, the customer concluded that the fatal hemorrhage was not related to the use of the embotrap as the device was used according to the ifu guidelines.There was no intraoperative bleeding that was attributed to the use of the device.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Hemorrhage and death are known potential adverse events associated with endovascular mechanical thrombectomy for acute ischemic stroke cases and are listed in the embotrap instructions for use (ifu) as such.The embotrap revascularization device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset.Patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.With the information provided, it is not possible to determine the root cause of the event.However, there are patient, procedural, and pharmacological factors that may have contributed.There is no indication that the device malfunctioned or that the event was related to the device design or manufacturing process.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 pa; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 12218929
• MDR Text Key: 263215846
• Report Number: 3011370111-2021-00062
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRATION CATHETER (ACE68, PENUMBRA).; GUIDEWIRE (200CM CHIKAI, ASAHI INTECC).; GUIDING CATHETER (90CM OPTIMO).; MICROCATHETER (0.027INCHES MARKSMAN, MEDTRONIC).; TRANSFORM, STRYKER BALLOON CATHETER.; ASPIRATION CATHETER (ACE68, PENUMBRA); GUIDEWIRE (200CM CHIKAI, ASAHI INTECC); GUIDING CATHETER (90CM OPTIMO),; MICROCATHETER (0.027INCHES MARKSMAN, MEDTRONIC); TRANSFORM, STRYKER BALLOON CATHETER
• Patient Outcome(s): Death