MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL IC 71, 132 CM, CE, ASP. IND.; CATHETER, PERCUTANEOUS

Catalog Number IC71132CA

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Vasoconstriction (2126)

Event Date 07/31/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The image review was done by cerenovus sr.Medical affairs director and the assessment is as follows: ¿the description of the complaint is clear, there is a vasospasm response to the target device and the device was caught by this spasm leading to difficulty in withdrawal.There is one image provided which shows elongation of the ica with spasm and focal dilatation.This vasospasm is likely due to the procedure.Vasospasm can happen upon placement of the devices and especially in elongated vessels¿.A manufacturing record evaluation was performed for the finished device 30927539 number, and no non-conformances related to the malfunction were identified.Section h3 - 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.

Event Description

It was reported, via a healthcare professional, that an ic 71, 132 cm, ce, asp.Ind.(ic71132ca/ 30927539) device was used during a thrombectomy procedure, when the user experienced maneuvering and withdrawal difficulty, during which the patient suffered the adverse event of an ¿arterial spasm¿.The event was further described: ¿attempt to probe left aci, embovac could not be pushed forward.Vessel elongated (picture available).Great force had to be used when retracting into the flowgate2 (stryker).When the catheter was out of the body, various deformations were found¿.The surgery was delayed by 10 minutes due to the reported event.The procedure successfully completed.No fragments were generated.The event did not affect the patient¿s status/ outcome.No further information is available at this time.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was received on (b)(6) 2023.Summary of the information provided: the information indicated that the 10-minute procedural delay caused by the event of arterial spasm was not clinically significant.The arterial spasm was treated with ¿nimodipine i.A.¿.The treating physician had ¿no ideas¿ as to any possible cause(s) or contributing factors of the event.The patient¿s baseline neurological status prior to the procedure was ¿acute stroke¿.The patient¿s neurological status after the event was noted as ¿improved clinical symptoms after evt¿.Regarding the initial report that ¿various deformations were found¿ on the device fracture when the catheter removed from the body, it was further commented, ¿device was kinked in multiple areas near distal tip¿.The withdrawal was performed as per the instructions for use (ifu).The current status of the patient was commented as ¿improved clinical symptoms¿.Relevant anatomical information including vessel characteristics were noted as ¿kinking and tortuosity of [internal carotid artery] ica¿.It was also commented that there will be no further information available regarding the patient¿s demographics and medical history.This additional information did not require changes regarding the reportability determination; therefore, no changes were made.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.Complaint conclusion: it was reported, via a healthcare professional, that an ic 71, 132 cm, ce, asp.Ind.((b)(6)) device was used during a thrombectomy procedure, when the user experienced maneuvering and withdrawal difficulty, during which the patient suffered the adverse event of an ¿arterial spasm¿.The event was further described: ¿attempt to probe left aci, embovac could not be pushed forward.Vessel elongated (picture available).Great force had to be used when retracting into the flowgate2 (stryker).When the catheter was out of the body, various deformations were found¿.The surgery was delayed by 10 minutes due to the reported event.The procedure successfully completed.No fragments were generated.The event did not affect the patient¿s status/ outcome.On (b)(6) 2023, an imaging review was done by cerenovus sr.Medical affairs director, dr.(b)(6) (neurointerventionalist), and was received on (b)(6) 2023.Per dr.Brouwer, ¿the description of the complaint is clear, there is a vasospasm response to the target device and the device was caught by this spasm leading to difficulty in withdrawal.There is one image provided which shows elongation of the ica with spasm and focal dilatation.This vasospasm is likely due to the procedure.Vasospasm can happen upon placement of the devices and especially in elongated vessels¿.This assessment was reviewed.Since this event resulted in a prolonged surgical procedure and the relationship of the embovac device to the reported event of ¿vasospasm¿ cannot be excluded, the event is being reported to the us fda as a conservative measure.Additional information was received on 24-aug-2023.Summary of the information provided: the information indicated that the 10-minute procedural delay caused by the event of arterial spasm was not clinically significant.The arterial spasm was treated with ¿nimodipine i.A.¿.The treating physician had ¿no ideas¿ as to any possible cause(s) or contributing factors of the event.The patient¿s baseline neurological status prior to the procedure was ¿acute stroke¿.The patient¿s neurological status after the event was noted as ¿improved clinical symptoms after evt¿.Regarding the initial report that ¿various deformations were found¿ on the device fracture when the catheter removed from the body, it was further commented, ¿device was kinked in multiple areas near distal tip¿.The withdrawal was performed as per the instructions for use (ifu).The current status of the patient was commented as ¿improved clinical symptoms¿.Relevant anatomical information including vessel characteristics were noted as ¿kinking and tortuosity of [internal carotid artery] ica¿.It was also commented that there will be no further information available regarding the patient¿s demographics and medical history.This additional information did not require changes regarding the reportability determination; therefore, no changes were made.A non-sterile ic 71, 132 cm, ce, asp.Ind.Was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed and the presence of hydrophilic coating was confirmed.Several kinked condition were noted along the entire length of the shaft of the catheter.A longitudinal compression of 6 cm was found at the distal shaft of the catheter along with several stretched and compressed conditions.The chronoprene section was found in a compressed flattened condition.The distal tip was also found compressed.Further inspection under microscopic magnification revealed that as a result of the compressed condition on the chronoprene section, the mesh structure was found stretched and the coating was found slightly torn.It was noted that as a result of the stretching condition the internal braided mesh was exposed.The catheter was confirmed to be within specifications for the inner diameter (id) and outer diameter (od).A manufacturing record evaluation was performed for the finished device 30927539 number, and no non-conformances related to the malfunction were identified.The tracking difficulty documented in the complaint could not be duplicated in the laboratory setting since such issue is most related to the patient anatomy, device manipulation, and device selection; however, the multiple damages found in the returned catheter appeared to be a translation of the difficulty while maneuvering the device.Based on this, the customer complaint was confirmed.It is possible that the base catheter could have trapped the softest area of the catheter against a vessel and could have caused the stretching upon retrieval, which ultimately resulted in the catheter being accordioned.According to the risk documentation, withdrawal difficulty is a potential failure mode of the large bore catheter that can occur during catheter removal from anatomy due to anatomical tortuosity.With the limited information available, a conclusive cause cannot be determined; however, given the broad sequence of events, there is no indication that the issue reported in the complaint is related to a manufacturing issue.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure is multifactorial.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) contain the following precautions: ¿ do not advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.¿ exercise care in handling the large bore catheter to reduce the chance of accidental damage.Vasospasm is a known potential complication associated with the use of the embovac aspiration catheter and is listed in the instructions for use (ifu) as such.The ifu for the embovac device also warns against advancing or withdrawing the device against resistance and is stated as the following: ¿do not advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the device against resistance could dislodge a clot, perforate a vessel wall, or damage the device¿.Nevertheless, the surgical procedure was prolonged by 10 minutes and the relationship of the embovac device to the reported event of ¿vasospasm¿ cannot be excluded.Therefore, this event will be conservatively reported to the us fda reporting under criteria 21 cfr 803, with the classification of ¿serious injury¿.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: IC 71, 132 CM, CE, ASP. IND.
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17602575
• MDR Text Key: 321727890
• Report Number: 3008114965-2023-00607
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191237
• 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,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30927539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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: FLOWGATE2 (STRYKER).
• Patient Outcome(s): Required Intervention; Life Threatening