MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X17 MM; STENT

Model Number 172014-CASJ-C

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

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 returned to the manufacturer for review.The investigation is underway.

Event Description

It was reported that an attempt was made to resheath the stent after 50% had been deployed; however, it was very stiff and was not able to be withdrawn after 70% had been retracted into the microcatheter.The microcatheter and stent were removed together from the patient without incident.The patient's condition has improved after the procedure.

Manufacturer Narrative

The stent and pusher were returned.A new microcatheter and introducer were used for the investigation.Upon initial investigation, there did not appear to be any damage to the stent.The stent was able to be resheathed both at 50% and 70% deployment without any issues.The stent was reloaded onto the provided pusher and advanced through a new headway 17 microcatheter smoothly.The stent was deployed out of the distal end of the microcatheter.The complaint is unconfirmed, as the stent was able to be resheathed without any issues, both at 50% and 70% deployment.The root cause for the complaint may have been due to tortuous anatomy preventing the stent from resheathing during the procedure.However, the root cause cannot be definitively determined.

• Brand Name: LVIS JR 2.5X17 MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9221777
• MDR Text Key: 191387650
• Report Number: 2032493-2019-00243
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00810170019104
• UDI-Public: (01)00810170019104(11)180807(17)210731(10)18080752P
• Combination Product (y/n): N
• PMA/PMN Number: D324109
• 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: 09/22/2019

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 Expiration Date: 07/31/2021
• Device Model Number: 172014-CASJ-C
• Device Lot Number: 18080752P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: 09/22/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 09/22/2019
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70