MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ANASTOCLIP VCS LARGE

Model Number 4000-07

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

We have not received the complaint device for evaluation and we were not able to verify the failure mode.Based on the complaint description the distances between clips were up to 0.8-1.0 mm where the ifu recommends placement as close as possible (not more than 0.5 mm between clips).Even though the root cause(s) of the incident remains inconclusive, it is likely that the patient condition (too friable tissue) and improper placement of the clips (distance between clips more than 0.5 mm, and improper apposition of the tissue) during the procedure contributed to the failure.Please note that we were not able to receive any additional information from the distributor in (b)(6), including the date of the incident and lot number.

Event Description

Spine dural rupture during laminectomy.10mm incision clipped with anstoclip vcs size l.Clips were reported to have been applied no more than 0.8-1.0 mm between each other.Additional hemostatic agent on top.No filtration after valsava technique applied.The procedure needed revision surgery 8 days post surgery because of dural fistula.During revision surgery dr.(b)(6) found: clips were attached just to one side of tissue; clips were out of place; leakage through the space between clips.

• Brand Name: ANASTOCLIP VCS LARGE
• Type of Device: ANASTOCLIP
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• Manufacturer Contact: vyacheslav kozin ; 63 second ave.; burlington, MA 01803 ; 7812212266
• MDR Report Key: 5385931
• MDR Text Key: 36655907
• Report Number: 1220948-2016-00002
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00840663102372
• UDI-Public: 00840663102372
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K962043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2015

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: Physician
• Device Model Number: 4000-07
• Device Catalogue Number: 4000-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention