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

Model Number ET009533

Device Problems Break (1069); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, during a thrombus removal of an acute ischemic stroke (ais), an unknown concomitant microcatheter was inserted and delivered to the lesion.A 5x33 embotrap ii revascularization device was inserted into an aspiration catheter (react, medtronic).They were retracted but the empotrap became stuck on the aspiration catheter.It was removed somehow but the empotrap became damaged.It was removed with a 3max, trevo, stryker.Device pictures was received.

Manufacturer Narrative

Product complaint #: (b)(4).Section b5: additional information indicated that no excessive force was applied to the device.The withdrawal of the device was performed as per the instructions for use (ifu).Section e1 - initial reporter phone: (b)(6).Complaint conclusion updated with additional information: as reported by the field, during a thrombus removal of an acute ischemic stroke (ais), an unknown concomitant microcatheter was inserted and delivered to the lesion.A 5x33 embotrap ii revascularization device (et009533, 20c089av) was inserted into an aspiration catheter (react, medtornic).They were retracted but the empotrap became stuck on the aspiration catheter.It was removed somehow but the empotrap became damaged.It was removed with a 3max, trevo, stryker.Device pictures were received.Additional information received indicated that after the 1st pass, the embotrap device was withdrawn to the react, and the physician felt strong resistance when the embotrap device was passing through the react at some point.So, the physician withdrawn both the embotrap device and react together.The devices were withdrawn from the patient¿s body and the embotrap device was then successfully removed from the react.The same embotrap device and the react were used for the 2nd pass.However, after the 2nd pass and during withdrawing the embotrap device, the same issue (strong resistance) occurred, so both devices were withdrawn from the patient¿s body together again.The embotrap device was successfully withdrawn from the react, but the physician visually confirmed damage (i.E.Deformation) to the embotrap device so the physician discontinued to use the device.Additional information indicated that no excessive force was applied to the device.The withdrawal of the device was performed as per the instructions for use (ifu).Photographs were received and visually analyzed.There are no major visible deformation or damage on the introducer sheath of the embotrap device, and the condition of the stent portion of the embotrap device could not be confirmed from the provided photos as it is stored inside of the insertion tool.Potential deformation (i.E.Slight kink) at the distal side of the react 71 catheter as well as deformation (i.E.Ovality shape) at the distal tip of the catheter were noted from the provided photos.These deformations are consistent with use.An embotrap ii 5x33 revasc.Device was returned for analysis.The visual inspection, under magnification of stent portion of the embotrap device indicated a deformation (i.E.Kink) at the proximal end of the inner channel which is consistent with attempts to overcome resistance in advancing or withdrawing the device.A strut fracture was also noted at the proximal side of the outer cage which may occur when excessive force was applied to the device.The returned embotrap device was successfully passed through a 0.0195¿ tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.The return embotrap device exhibited no issues upon retraction or advancement.The returned embotrap device was also successfully deployed distal to, and withdrawn through, a 0.071¿ intermediate catheter without any resistance noted.The visual inspection of the react 71 intermediate catheter indicated a partial delamination of the circumferential braid was noted at one of the terminal ends.Closer examination of the lumen at the distal end of the react 71 intermediate catheter indicated that the braid delamination was protruding the catheter lumen.During a simulated replication of the withdraw of a embotrap device into the returned react 71 catheter full withdrawal of the stent like assembly into the catheter lumen could not be achieved.The point at which the stent like assembly engaged with the potential snag point (protruding wire) corresponded with the fracture location on the returned embotrap device.A review of the manufacturing documentation associated with lot number lot # 20c089av presented no issues during the manufacturing or inspection process that can be related to the reported event.The reported customer complaint ¿embotrap - withdrawal difficulty into guide/intermediate catheter ¿ was confirmed.Based on the investigation performed it is concluded that the resistance to withdrawal of the embotrap device through the returned react 71 intermediate catheter was a braid defect in the lumen of the intermediate catheter.The defect, a braid wire protruding into the lumen of the intermediate catheter near the distal tip, created an entanglement of the embotrap.It is concluded that attempts by the physician to resolve this entanglement, perceived by the physician as a significant resistance to withdrawal, resulted in a fracture of the embotrap outer cage strut.Neither the device history record review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.The instructions for use (ifu) notes that if withdrawal into the guide catheter is difficult (as may be the case with a large clot burden) then deflate the balloon (if applicable) and withdraw the guide, microcatheter and device together through the introducer sheath.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: additional information received indicated that reported that after the 1st pass, the embotrap device was withdrawn to the react, and the physician felt strong resistance when the embotrap device was passing through the react at some point.So, the physician withdrew both the embotrap device and react together.The devices were withdrawn from the patient's body and the embotrap device was then successfully removed from the react.The same embotrap device and the react were used for the 2nd pass.However, after the 2nd pass and during withdrawing the embotrap device, the same issue (strong resistance) occurred, so both devices were withdrawn from the patient body together again.The embotrap device was successfully withdrawn from the react, but the physician visually confirmed damage (i.E.Deformation) to the embotrap device so the physician discontinued using the device.Photographs were received by the japan bq team.Based on the visual analysis of the photos received, there are no major visible deformation or damage on the introducer sheath of the embotrap device, and the condition of the stent portion of the embotrap device could not be confirmed from the provided photos as it is stored inside of the insertion tool.Potential deformation (i.E.Slight kink) at the distal side of the react 71 catheter as well as deformation (i.E.Ovality shape) at the distal tip of the catheter were noted from the provided photos.These deformations are consistent with use.A review of the manufacturing documentation associated with lot number: 20c089av presented no issues during the manufacturing or inspection process that can be related to the reported event.In conclusion, the investigation on the provided photographs could not determine the potential cause of the reported event (i.E.Strong resistance during withdrawing the embotrap device through the react 71 catheter, as well as deformation noted at the stent portion of the embotrap device) as the condition of the embotrap device and the react 71 could not be confirmed clearly from the photographs.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.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).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 field, during a thrombus removal of an acute ischemic stroke (ais), an unknown concomitant microcatheter was inserted and delivered to the lesion.A 5x33 embotrap ii revascularization device (et009533, 20c089av) was inserted into an aspiration catheter (react, medtornic).They were retracted but the empotrap became stuck on the aspiration catheter.It was removed somehow but the empotrap became damaged.It was removed with a 3max, trevo, stryker.Device pictures were received.Additional information received indicated that after the 1st pass, the embotrap device was withdrawn to the react, and the physician felt strong resistance when the embotrap device was passing through the react at some point.So, the physician withdrawn both the embotrap device and react together.The devices were withdrawn from the patient¿s body and the embotrap device was then successfully removed from the react.The same embotrap device and the react were used for the 2nd pass.However, after the 2nd pass and during withdrawing the embotrap device, the same issue (strong resistance) occurred, so both devices were withdrawn from the patient¿s body together again.The embotrap device was successfully withdrawn from the react, but the physician visually confirmed damage (i.E.Deformation) to the embotrap device so the physician discontinued to use the device.Photographs were received and visually analyzed.There are no major visible deformation or damage on the introducer sheath of the embotrap device, and the condition of the stent portion of the embotrap device could not be confirmed from the provided photos as it is stored inside of the insertion tool.Potential deformation (i.E.Slight kink) at the distal side of the react 71 catheter as well as deformation (i.E.Ovality shape) at the distal tip of the catheter were noted from the provided photos.These deformations are consistent with use.An embotrap ii 5x33 revasc.Device was returned for analysis.The visual inspection, under magnification of stent portion of the embotrap device indicated a deformation (i.E.Kink) at the proximal end of the inner channel which is consistent with attempts to overcome resistance in advancing or withdrawing the device.A strut fracture was also noted at the proximal side of the outer cage which may occur when excessive force was applied to the device.The returned embotrap device was successfully passed through a 0.0195¿ tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.The return embotrap device exhibited no issues upon retraction or advancement.The returned embotrap device was also successfully deployed distal to, and withdrawn through, a 0.071¿ intermediate catheter without any resistance noted.The visual inspection of the react 71 intermediate catheter indicated a partial delamination of the circumferential braid was noted at one of the terminal ends.Closer examination of the lumen at the distal end of the react 71 intermediate catheter indicated that the braid delamination was protruding the catheter lumen.During a simulated replication of the withdraw of a embotrap device into the returned react 71 catheter full withdrawal of the stent like assembly into the catheter lumen could not be achieved.The point at which the stent like assembly engaged with the potential snag point (protruding wire) corresponded with the fracture location on the returned embotrap device.A review of the manufacturing documentation associated with lot number lot # 20c089av presented no issues during the manufacturing or inspection process that can be related to the reported event.The reported customer complaint ¿embotrap - withdrawal difficulty into guide/intermediate catheter ¿ was confirmed.Based on the investigation performed it is concluded that the resistance to withdrawal of the embotrap device through the returned react 71 intermediate catheter was a braid defect in the lumen of the intermediate catheter.The defect, a braid wire protruding into the lumen of the intermediate catheter near the distal tip, created an entanglement of the embotrap.It is concluded that attempts by the physician to resolve this entanglement, perceived by the physician as a significant resistance to withdrawal, resulted in a fracture of the embotrap outer cage strut.Neither the device history record review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.The instructions for use (ifu) notes that if withdrawal into the guide catheter is difficult (as may be the case with a large clot burden) then deflate the balloon (if applicable) and withdraw the guide, microcatheter and device together through the introducer sheath.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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
• MDR Report Key: 10785160
• MDR Text Key: 214627157
• Report Number: 3011370111-2020-00082
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• 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,Followup,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20C089AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 12/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3MAX REPERFUSION CATHETER.; REACT ASPIRATION CATHETER, MEDTORNIC.; TREVO CATHETER, STRYKER.; 3MAX REPERFUSION CATHETER; REACT ASPIRATION CATHETER, MEDTORNIC; TREVO CATHETER, STRYKER