MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452200

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/15/2023

Event Type  Death  

Event Description

It was reported, via a healthcare professional, that an eu ent4.5mmd 22mml wno dstl tp stent - vascular reconstruction device (enc452200/ 6920536) and a prowler select plus 150/5cm microcatheter (606s255x/ 30963228) was used for a ¿stent-assisted aneurysm embolization¿ procedure for a ¿ruptured posterior communicating artery aneurysm¿, during which the prowler select plus microcatheter ¿kinked/bent-in patient¿ and the ¿catheter (body/shaft) exhibited inadequate support¿ (the catheter does not provide enough stability; there may be difficulty maintaining catheter position while advancing other devices through it).The microcatheter subsequently migrated into the aneurysm causing the ruptured aneurysm to bleed more.The microcatheter and stent were removed from the patient¿s body and the surgery was completed.The patient was in a comatose state prior to the procedure and remained in a coma after the procedure.It was decided by patient¿s family to discharge the patient from the hospital.The patient then passed away at home.The event description was reported as such: ¿it was reported that patient suffered from ruptured posterior communicating artery aneurysm and performed procedure of stent-assisted aneurysm embolization.During the procedure, the patient was already in coma when doctor was going to anaesthetize the patient.Physician filled the aneurysm with 1 coil (other brand), and placed microcatheter in target site and then delivered the stent into the microcatheter.Suddenly, the microcatheter was twisted and migrated into the aneurysm.Bleeding from the ruptured aneurysm increased.Physician removed the microcatheter and stent from patient body and completed the surgery.The patient has been in a coma.The patient has been discharged from the hospital which decided by the patient¿s family.The patient passed away in home¿.Additional information was received on 29-aug-2023.Summary of the information provided: the information indicated that the patient¿s date of death is unknown and unobtainable.Regarding if there was an alleged product malfunction associated with the enterprise device, this information is ¿unobtainable¿.The catheter was at the target lesion.There was no difficulty in positioning the prowler select.It was further added that the patient was a female, suffering from a posterior communicating ruptured aneurysm.Additional patient information is ¿unobtainable¿.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section a2: date of death is not available.Section e1.Initial reporter phone: (b)(6).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.This information was not provided in the reported event or available at the time of report submission.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00628 and 3008114965-2023-00629.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h10.A non-sterile eu ent4.5mmd 22mml wno dstl tp stent - vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the stent component was noted detached from the delivery system and not returned for evaluation.The delivery wire was found still inside the introducer.No damages were observed on these components.No damages were observed on the delivery wire under the microscope.Residues of dried blood were noted.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.No further investigation is being conducted as there is no alleged quality issue against the reprocessed catheter.This investigation is considered complete at this time; if additional information is received at a later time, this investigation will be updated, and further actions can be taken as needed.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since no product defect was identified, no capa activity is required.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EU ENT4.5MMD 22MML WNO DSTL TP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17649709
• MDR Text Key: 322260037
• Report Number: 3008114965-2023-00628
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: ENC452200
• Device Lot Number: 6920536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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: PROWLER SELECT PLUS 150/5CM
• Patient Outcome(s): Death
• Patient Sex: Female