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

Model Number 212917-CAS-D-EMEA

Device Problem Activation Failure (3270)

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

Event Date 01/12/2021

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 the delivery system was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that during placement of an lvis d stent, the proximal portion of the stent would not open.The stent was fully deployed and could not be resheated.A guidewire was used to open the proximal portion of the stent.There was no further intervention and no reported patient injury or sequela was reported.

Manufacturer Narrative

Fluoroscopic images provided by the user show the lvis stent narrowed and not expanded at its distal end.The pusher was returned for evaluation; the stent remains implanted in the patient.The physical evaluation of the returned pusher did not find any damage or other anomaly that would have caused or contributed to the reported complaint.Without the return of the implant, the investigation cannot determine if a condition existed that would have caused or contributed to the complaint.D9: although stent not returned, the delivery pusher was returned for evaluation.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11325777
• MDR Text Key: 238718554
• Report Number: 2032493-2021-00044
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429101001
• UDI-Public: (01)00842429101001(11)200722(17)230630(10)20072255A
• Combination Product (y/n): N
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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: 06/30/2023
• Device Model Number: 212917-CAS-D-EMEA
• Device Lot Number: 20072255A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 81