MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number LTXXX

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure to Anastomose (1028); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Publication year for the journal article is 2009.This report is related to a journal article; therefore, no product will be returned for analysis.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.

Event Description

It was reported that during review of journal article, title: high output chyle leak after neck surgery: the role of video-assisted thoracoscopic surgery.Authors: khalid abdel-galil, richard milton, james mccaul, citation: british journal of oral and maxillofacial surgery 47 (2009) 478¿480.This study described a case where an excessive chylous leak also contributed to the failure of two free flaps in a patient.A (b)(6) year-old man had an adenoid cystic carcinoma of the left submandibular gland and floor of mouth removed.He had tumour resection, left selective neck dissection (levels i¿iv), and reconstruction of the oral defect with a free radial forearm flap.During operation, the thoracic duct was identified and ligated.At the end of the first postoperative day, the patient had excessive swelling of the lower neck and leakage of serous fluid that was chylous in nature.He was taken back to theatre and repair was done.Over the next 2 days there was considerable chylous drainage (>1000 ml/day) in his neck drains, with associated compromise of the free flap.He was returned to theatre on the third postoperative day when further chylous collection was evacuated from the neck.Sutures, ligating clips (ligaclips) (ethicon) and fibrin sealant (tisseel) were used to control the flow.The patient continued to have an excessive chylous output through the neck drains despite controlled nasogastric feeding with medium chain triglycerides.The patient was referred for thoracoscopic ligation of the thoracic duct on the ninth postoperative day.He made an uneventful recovery with immediate cessation of the cervical chylous leak.In conclusion, in case when there is an excessive chylous leak and compromise of the flap, the leak should be addressed before any further reconstruction by free tissue transfer and high flow chylous leaks that are complicated by chylothorax should be treated by transthoracic ligation of the thoracic duct.

Manufacturer Narrative

(b)(4).Date sent: 5/29/2020.B5: event description: journal article doi is https://doi.Org/10.1016/j.Bjoms.2009.04.030.H6: patient codes: failure to anastomose.

• Brand Name: LIGACLIP EXTRA TITANIUM CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10059957
• MDR Text Key: 194698166
• Report Number: 3005075853-2020-02615
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LTXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention