MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Defective Device (2588)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

As reported by the field, this was a stent assist coil embolization to an aneurysm at the anterior communicating artery.During procedure, the physician released a eu 4.5x22mm stent 12 mm dw tip (enc452212, 7591276), however, it was found that the stent body was shorter than intended and the stent just covered the neck of aneurysm.After 3d measurement, the stent body was only about 14mm.Additional information received indicated that the device had not been manipulated in any way prior to appearing out of shape.The length is different than printed on the label.The device was selected based in instruction for use vessel/stent measurements.The parent vessel diameter was 2.5mm.The physician selected stent of appropriate size.After the stent released in patient, it was found the actual stent body was shorter than intended.The stent just covered the aneurysm neck.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4); information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6); the device remains implanted; therefore, no further investigation can be performed.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.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.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).Images were received, and the review was made by an independent physician; the results are shown below: "the images provided support what was described before.The images are however only in one direction, so the measurement is not necessarily according to the central-luminal line.The real length of the segment is therefore not sure.The stent is located too proximally according to the physicians liking, but given the proximal length available, it could have been deployed more distally".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).Section b5: additional information received indicated that after the stent was released in the patient, the physician completed the surgery.There was no additional stent used to complete the procedure or any other additional intervention used.Complaint conclusion: as reported by the field, this was a stent assist coil embolization to an aneurysm at the anterior communicating artery.During procedure, the physician released a eu 4.5x22mm stent 12 mm dw tip (enc452212, 7591276), however, it was found that the stent body was shorter than intended and the stent just covered the neck of aneurysm.After 3d measurement, the stent body was only about 14mm.Additional information received indicated that the device had not been manipulated in any way prior to appearing out of shape.The length is different than printed on the label.The device was selected based in instruction for use vessel/stent measurements.The parent vessel diameter was 2.5mm.The physician selected stent of appropriate size.After the stent released in patient, it was found the actual stent body was shorter than intended.The stent just covered the aneurysm neck.There was no patient injury reported.Additional information received indicated that after the stent was released in the patient, the physician completed the surgery.There was no additional stent used to complete the procedure or any other additional intervention used.The device remains implanted; therefore, no further investigation can be performed.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.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Per the instructions for use (ifu) select a stent length that is at least 10 mm longer than the aneurysm neck to maintain a minimum of 5 mm on either side of the aneurysm neck.A large differential in diameter between the proximal and distal segments of the parent vessel may increase the risk of stent migration.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 4.5X22MM STENT 12 MM DW TIP
• 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: 17116775
• MDR Text Key: 317912274
• Report Number: 3008114965-2023-00382
• 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,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Device Lot Number: 7591276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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