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

Model Number MV-L453221

Device Problem Activation Failure (3270)

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

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported 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.The remainder of the device was discarded by the hospital and not returned to the manufacturer for analysis.Additionally, procedural or post-procedural images were not provided; therefore, the reported event cannot be confirmed.

Event Description

It was reported that a lvis d was implanted to treat an aneurysm and initially opened distally, but then no longer advanced; the stent had detached inside of the microcatheter.The delivery pusher was removed and a guide wire was used to push the remainder of the device into position, but the proximal part of the stent did not open.The physician attempted to expand the stent with a balloon, but it could not advance into position.A guidewire was used to opened the stent a little more, but no further improvement could be made and the procedure was completed there was no reported patient injury.The patient's current condition is reported to be "no health damage.".

Manufacturer Narrative

Additional information received 4/6/21 indicated that as of (b)(6) 2021, the stent was still not fully open.There was no "health damage that could have been caused by this event." follow up examinations will be conducted one month and three months after the procedure.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11532793
• MDR Text Key: 249239134
• Report Number: 2032493-2021-00088
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892041495
• UDI-Public: (01)04987892041495(11)190819(17)220731(10)19081954G
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: MV-L453221
• Device Lot Number: 19081954G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention