MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER

Catalog Number FRS21452299

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not available / 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.A review of manufacturing documentation associated with this lot (l16306) presented no issues during the manufacturing or inspection processes related to the reported complaint.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.

Event Description

The healthcare professional reported that during a thrombectomy procedure, the physician reported that resistance was felt during the attempt to deliver the 4.5 mm revive se thrombectomy device (frs21452299 / l16306).When the physician retracted the stent, it was observed that the stent body was kinked and deformed.A competitor stent was used to complete the procedure.There was no report of any patient adverse event or complication.On 08-jul-2022, additional information was received.The information indicated that the procedure was targeting a recanalization of the m1 segment of the middle cerebral artery (mca).The 4.5 mm revive se thrombectomy device was used with the recommended 0.021 inch microcatheter, a rebar¿ 18 microcatheter (medtronic) was used.Continuous flush was maintained through the microcatheter.It was reported that the revive se device was captured two times.The information indicated that ¿if the first thrombectomy was unsuccessful, use the stent again to retrieve the thrombus.¿ the device was removed with the catheter if not fully retracted.The revive se device was used in two passes to attempt clot retrieval.The same rebar¿ 18 microcatheter was used with the replacement device to complete the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to report that multiple attempts to obtain product for analysis were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.[conclusion]: the healthcare professional reported that during a thrombectomy procedure, the physician reported that resistance was felt during the attempt to deliver the 4.5 mm revive se thrombectomy device (frs21452299 / l16306).When the physician retracted the stent, it was observed that the stent body was kinked and deformed.A competitor stent was used to complete the procedure.There was no report of any patient adverse event or complication.On 08-jul-2022, additional information was received.The information indicated that the procedure was targeting a recanalization of the m1 segment of the middle cerebral artery (mca).The 4.5 mm revive se thrombectomy device was used with the recommended 0.021 inch microcatheter, a rebar¿ 18 microcatheter (medtronic) was used.Continuous flush was maintained through the microcatheter.It was reported that the revive se device was captured two times.The information indicated that ¿if the first thrombectomy was unsuccessful, use the stent again to retrieve the thrombus.¿ the device was removed with the catheter if not fully retracted.The revive se device was used in two passes to attempt clot retrieval.The same rebar¿ 18 microcatheter was used with the replacement device to complete the procedure.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l16306) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Multiple attempts to obtain product for analysis were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.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.With the information available and without the revive se thrombectomy device complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 17-oct-2022.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, 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.

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 during a thrombectomy procedure, the physician reported that resistance was felt during the attempt to deliver the 4.5 mm revive se thrombectomy device (frs21452299 / l16306).When the physician retracted the stent, it was observed that the stent body was kinked and deformed.A competitor stent was used to complete the procedure.There was no report of any patient adverse event or complication.On 08-jul-2022, additional information was received.The information indicated that the procedure was targeting a recanalization of the m1 segment of the middle cerebral artery (mca).The 4.5 mm revive se thrombectomy device was used with the recommended 0.021 inch microcatheter, a rebar¿ 18 microcatheter (medtronic) was used.Continuous flush was maintained through the microcatheter.It was reported that the revive se device was captured two times.The information indicated that ¿if the first thrombectomy was unsuccessful, use the stent again to retrieve the thrombus.¿ the device was removed with the catheter if not fully retracted.The revive se device was used in two passes to attempt clot retrieval.The same rebar¿ 18 microcatheter was used with the replacement device to complete the procedure.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.5 mm revive se thrombectomy device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that only the delivery wire with the stent were returned for evaluation.Under microscopic inspection, it was found that the stent was in good condition no abnormalities were found on it (i.E., no kinks, no bents, or broken struts).The resistance encountered during the procedure could not be evaluated through functional testing since only the delivery wire with the stent were returned for evaluation.The customer complaint regarding a stent kinked and deformed was not confirmed as the stent was found to be undamaged; there is no evidence that the stent was subjected to excessive force.Clinical and intra-procedural factors, including device manipulation, may have contributed to the reported failure.With the information available, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.A review of manufacturing documentation associated with this lot (l16306) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendation: ¿ if resistance is felt when re-advancing the microcatheter over the expanded basket, stop and determine the cause before proceeding.¿ if excessive resistance is felt while withdrawing revive pv device into the tip of the guiding catheter or a suction lock of the aspiration syringe is encountered, then remove guide catheter, microcatheter and revive pv device together as a unit to the introducer sheath.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.H.6: the code ¿no findings available (c20)¿ was used in the investigation findings because the resistance encountered during the procedure could not be evaluated through functional testing since only the delivery wire with the stent were returned for evaluation.This code corresponds with the ¿cause not established (d15)¿ in the investigation conclusions.The code ¿no device problem found (c19)¿ was used in the investigation findings because the issue documented in the complaint related to the stent body was kinked and deformed was not confirmed as the stent was found to be undamaged; there is no evidence that the stent was subjected to excessive force.This code corresponds with the ¿no defect found (d14)¿ in the investigation conclusion.Updated sections: 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: REVIVE SE 4.5MM OUS
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15048115
• MDR Text Key: 296236396
• Report Number: 3008114965-2022-00469
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00878528000006
• UDI-Public: 878528000006
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: FRS21452299
• Device Lot Number: L16306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 09/01/2022; 10/17/2022; 10/20/2022
• Supplement Dates FDA Received: 09/01/2022; 10/17/2022; 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2019
• 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: REBAR¿ 18 MICROCATHETER (MEDTRONIC)