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

Model Number 213517-CAS-D-CN

Device Problem Material Separation (1562)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that when delivering the stent with the right femoral artery approach, resistance was encountered and continued to decrease.The physician found the far end of the delivery guide wire had protruded more from the main body of the stent, and the three marker points at the near end were separated. after the stent was removed, the distal end of the stent was deformed. the replacement of the same model of stent released smoothly, the procedure was completed.The patient's vital signs were stable, and conventional dual antibody and postoperative maintenance of metered tirofiban medications were used.

Manufacturer Narrative

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.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

Please see section h10 for device investigation results.

Manufacturer Narrative

Investigation conclusion: 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 and fully open upon deployment without resistance.All marker coils were present on both the proximal and distal ends of the stent.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.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• 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: 18196934
• MDR Text Key: 328973054
• Report Number: 2032493-2023-01074
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429115893
• UDI-Public: (01)00842429115893(11)230511(17)260430(10)0000360151
• 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: 12/11/2023

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: 213517-CAS-D-CN
• Device Lot Number: 0000360151
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 77 KG