MAUDE Adverse Event Report: UNK_THROMBECTOMY NEURAVI; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_THROMBECTOMY NEURAVI

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The expiration date of the device is not known as the device lot number is not available / not reported.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that during an endovascular a report from the field indicated that during an endovascular mechanical thrombectomy of a right middle cerebral artery (mca) (m2 segment) occlusion, three passes were made with a 132cm embovac 71 aspiration catheter (ic71132ca / 30546092), trevo trak 21 microcatheter (stryker), and embotrap ii revascularization device (unknown product code & lot number) but the early frontal branch of the m1 segment became blocked.There was partial reperfusion at the target occlusion but the early frontal branch m1 segment was newly blocked.The physician also noted after the third pass that the ¿relatively long catheter part¿ of the embovac was crushed and the concomitant trevo trak 21 microcatheter was not able to pass through the device.The physician replaced the embovac with a competitor aspiration catheter in order to perform a pass at the newly occluded early frontal branch of the m1 segment.The pass was made in combination with the embotrap ii device, but the vessel could not be reopened.Imaging then showed re-occlusion at the distal m1 ¿for some reason,¿ so the physician performed an additional pass with the competitor aspiration catheter and a 4mm competitor stent retriever to obtain partial recanalization.There was another pass performed with the same system at the early frontal branch of the m1, but revascularization could not be obtained.The final / end of procedure thrombolysis in cerebral infarction (tici) score was 2a.A chikai guidewire (asahi intecc) and 9f optimo¿ balloon guide catheter (tokai medical) were also used during the procedure.The embovac had been delivered to the m1 segment.The physician commented that the inner lumen of the embovac catheter probably became crushed because suction had been performed three times.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Arterial occlusion is a known potential adverse event associated with the use of the embotrap ii and embovac in endovascular mechanical thrombectomy.The nature of the blood flow reduction (i.E., arterial spasm, stenosis, thromboembolism) was not reported.With the information provided, it is not possible to determine the root cause of the event.However, there are vessel characteristics, patient, and procedural factors that may have contributed.During these interventional procedures, the devices are advanced and withdrawn through pre-existing thrombotic lesions with risk of embolization of thrombus, vessel spasm, and acute occlusion.Since the arterial occlusion required additional intervention to preclude permanent damage to a body structure and the relationship of the devices to the reported event cannot be excluded, the event meets mdr reporting criteria for both the embovac and embotrap.Treatment failure is a known potential outcome associated with endovascular mechanical thrombectomy.The embotrap ii 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.The root cause of the inability to achieve mtici score of 2b or higher after three embotrap passes cannot be determined.However, there are clinical and procedural factors including clot burden/characteristics, anatomical challenges, and operator technique that may have contributed to the event.Device ineffective with treatment failure does not meet mdr reporting criteria since the outcome does not appear to be related to a malfunction of the device but likely to the natural progression of the underlying disease process.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00458.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an endovascular mechanical thrombectomy of a right middle cerebral artery (mca) (m2 segment) occlusion, three passes were made with a 132cm embovac 71 aspiration catheter (ic71132ca / 30546092), trevo trak 21 microcatheter (stryker), and embotrap ii revascularization device (unknown product code & lot number) but the early frontal branch of the m1 segment became blocked.There was partial reperfusion at the target occlusion but the early frontal branch m1 segment was newly blocked.The physician also noted after the third pass that the ¿relatively long catheter part¿ of the embovac was crushed and the concomitant trevo trak 21 microcatheter was not able to pass through the device.The physician replaced the embovac with a competitor aspiration catheter in order to perform a pass at the newly occluded early frontal branch of the m1 segment.The pass was made in combination with the embotrap ii device, but the vessel could not be reopened.Imaging then showed re-occlusion at the distal m1 ¿for some reason,¿ so the physician performed an additional pass with the competitor aspiration catheter and a 4mm competitor stent retriever to obtain partial recanalization.There was another pass performed with the same system at the early frontal branch of the m1, but revascularization could not be obtained.The final / end of procedure thrombolysis in cerebral infarction (tici) score was 2a.A chikai guidewire (asahi intecc) and 9f optimo¿ balloon guide catheter (tokai medical) were also used during the procedure.The embovac had been delivered to the m1 segment.The physician commented that the inner lumen of the embovac catheter probably became crushed because suction had been performed three times.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6)2021.[additional information]: on 04-nov-2021, additional information was received.The information indicated that the procedure was considered completed with the tici 2a score.Procedural films / images are not provided.There was no clinically significant delay in the procedure.E.1: the initial reporter phone: (b)(6).This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00458 and 3011370111-2021-00113.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: UNK_THROMBECTOMY NEURAVI
• Type of Device: CATHETER, THROMBUS RETRIEVER
• MDR Report Key: 12530279
• MDR Text Key: 280909767
• Report Number: 3011370111-2021-00113
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THROMBECTOMY NEURAVI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• 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
• Treatment: 132CM EMBOVAC 71 ASP. CATHETER.; 9F OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL).; CHIKAI GUIDEWIRE (ASAHI INTECC).; TREVO TRAK 21 MICROCATHETER (STRYKER).
• Patient Outcome(s): Required Intervention