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

Model Number	4000-07
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Serious Injury
Additional 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 chile, including the date of the incident and lot number.Device was not returned for evaluation.
Event or Problem Description
Spine dural rupture during laminectomy.15mm incision clipped with anastoclip vcs size large.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 24hrs post op.Because of csf leakage.Imaging showed infiltration into the psoas and surgical incision.During revision surgery dr.(b)(6) found that: 1.Clips were out of place.2.Clips were attached just to one side of tissue.3.Cracked borders of the tissue.

• Brand Name: ANASTOCLIP VCS LARGE
• Common Device Name: ANASTOCLIP
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• MDR Report Key: 5385923
• Report Number: 1220948-2016-00001
• Device Sequence Number: 10880434
• Product Code: FZP
• UDI-Device Identifier: 00840663102372
• UDI-Public: 00840663102372
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K962043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Model Number: 4000-07
• Device Catalogue Number: 4000-07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2016
• 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: Other; Required Intervention