MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR.; INTRACRANIAL COIL-ASSIST STENT

Model Number 172020-CASJ-C-CN

Device Problem Retraction Problem (1536)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged resheathing issue as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.

Event Description

As reported, segment a2 aneurysm, stent assisted embolization.The microcatheter was in place, filled with a coil, ready to release the stent, because the blood vessels were tortuous, pushing resistance was relatively high.The stent was in place, the microcatheter was withdrawn, and the stent was ready to be released.After the head end of the stent was opened, continued to release the stent, and the stent fell down, and could not fully cover the tumor neck, ready to recover the stent.When the stent was recovered to the proximal end, the resistance was very high, and it could not be completely recovered into the microcatheter.The stent and the microcatheter were removed together.After cleaning the stent, the microcatheter was in place again, and the marked points at the head of the stent did not separate.After continued to release for a longer distance, it still could not be opened, and the resistance was great.Removed the stent and found the head end was deformed.Since no stent of the same type was available, the physician chose to complete the procedure with coils.It was reported there was no patient injury.

Manufacturer Narrative

The stent was returned loaded in the introducer.The stent was advanced into an in-house microcatheter during the investigation, and was able to deploy and resheathe without resistance.The stent was undamaged upon deployment.The investigation of the returned stent system found the stent returned loaded in the introducer.Replication testing was performed and found the stent was able to successfully advance through an in-house microcatheter, deploy, resheathe, and fully open without resistance.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The torturous anatomy may have caused or contributed to the alleged issue as described in the reported event; however, this investigation could not replicate the anatomical environment to test and assess the device in the exact conditions experienced during the procedure.

Event Description

As reported, segment a2 aneurysm, stent assisted embolization.The microcatheter was in place, filled with a coil, ready to release the stent, because the blood vessels were tortuous, pushing resistance was relatively high.The stent was in place, the microcatheter was withdrawn, and the stent was ready to be released.After the head end of the stent was opened, continued to release the stent, and the stent fell down, and could not fully cover the tumor neck, ready to recover the stent.When the stent was recovered to the proximal end, the resistance was very high, and it could not be completely recovered into the microcatheter.The stent and the microcatheter were removed together.After cleaning the stent, the microcatheter was in place again, and the marked points at the head of the stent did not separate.After continued to release for a longer distance, it still could not be opened, and the resistance was great.Removed the stent and found the head end was deformed.Since no stent of the same type was available, the physician chose to complete the procedure with coils.It was reported there was no patient injury.

• Brand Name: LVIS JR.
• Type of Device: INTRACRANIAL COIL-ASSIST STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18499616
• MDR Text Key: 333115706
• Report Number: 2032493-2024-00040
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103319
• UDI-Public: (01)00842429103319(11)220210(17)250131(10)0000153897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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 Model Number: 172020-CASJ-C-CN
• Device Lot Number: 0000153897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2024
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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
• Patient Age: 68 YR
• Patient Weight: 70 KG