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

Model Number	172516-LVISJ-C-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-relatedissues relevant to the complaint that occurred during manufacturing of the device.The reported complaint is unconfirmed as the stent was able to fully open upon deployment during the investigation.The distortion of the proximal long loops is consistent with the stent being retrieved from the vessel with a snare during the procedure.The distal long loops were damaged while loading the stent during the investigation.
Event or Problem Description
It was reported that after deploying the lvis jr.Stent, the back half of the stent leading to the proximal end did not open and appeared flattened out.The stent was removed with a snare.There was no reported patient injury.

• Brand Name: LVIS JR.
• Common Device Name: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 12662138
• Report Number: 2032493-2021-00415
• Device Sequence Number: 4852914
• Product Code: QCA
• UDI-Device Identifier: 00842429100837
• UDI-Public: (01)00842429100837(11)201021(17)230930(10)20102155F
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 172516-LVISJ-C-PMA
• Device Catalogue Number: 172516-LVISJ
• Device Lot Number: 20102155F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR