MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRALUMINAL SUPPORT DEVICE

Model Number LEV3534-MVE

Device Problems Difficult to Remove (1528); Separation Failure (2547); Material Twisted/Bent (2981)

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

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance 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.The device was implanted in the patient and not returned to the manufacturer for analysis.Medical imaging provided and is currently being analyzed.At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u.S.The complaint is being reported now as based on this product meeting similar product criteria.

Event Description

It was reported that during treatment of an acomm aneurysm, an atlas was deployed in ipsilateral a1 with catheter jailed in the aneurysm.The guidewire and catheter were delivered to the contralateral a1 with round the work technique (tortuous, difficult anatomy).The lvis evo was partially deployed in the a2 and gentle traction on the system was used to correct the device position into the parent artery.Further deployment resulted in kinked, twisted braid of the stent and subsequently the delivery pusher lead wire stuck in the construct.The device could not be re-sheathed or advanced.The evo was deployed with the proximal end just at the ica terminus.A pipeline shield at distal ica to hold wire intact to the carotid.Casper stent deployed in the neck and wire was cut off at the wrist.Patient on ticagrelor and aspirin.Sent to theatre with vascular team for arterial cut down and removal of proximal end of pusher wire.Vascular consult and operation for removal of proximal end of pusher wire.Both acas patent on final dsa.The patient was reported to have done well overnight and the following morning.

Manufacturer Narrative

A set of procedure images were provided for this investigation.The images show an acom aneurysm with coils inside it, an atlas stent spanning from left a2 to distal a1/acom, an evo stent from right a2 to acom, an evo stent from distal left a1 to left ica terminus, a pipeline shield from left ica terminus to ophthalmic segment of the ica and a casper stent at the left cca/ica.The left a1, pipeline, and casper stent are seen to pin down the pusher/delivery wire that could not be retrieved.There are no apparent emboli.The cause for the non-retrieval of the delivery/pusher wire is not evident on these images.The physical device was not returned for evaluation.Without the return and physical evaluation of the device, the investigation cannot determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: LVIS EVO
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13935189
• MDR Text Key: 288114113
• Report Number: 2032493-2022-00116
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00842429103531
• UDI-Public: (01)00842429103531(11)210914(17)240831(10)0000077873
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LEV3534-MVE
• Device Lot Number: 0000077873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male