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

Catalog Number LT300

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Obstruction/Occlusion (2422); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during the review of a journal article, title : iatrogenic tracheal stenosis after yasui operation in a neonate with aortic atresia and type b aortic interruption.Author : madan m.Maddali, md, pranav s.Kandachar, mch, abdoulah mohsen, nishant r.Arora, md, francois lacour-gayet, md.Citation: journal of cardiothoracic and vascular anesthesia 33 (2019) 1370-1374.Respiratory complications due to external compression of the airways can occur after procedures that involve repair of an interrupted aortic arch on newborns.One such procedure that includes reconstruction of an interrupted aortic arch is the yasui operation that originally was described for the primary repair of type a and b aortic interruption with severe aortic stenosis in neonates with adequate-sized ventricles.An 11-day-old female patient with large atrial septal defect and a large ventricular septal defect, deletion of the chromosome 22q11 locus and confirmed di george syndrome underwent yasui operation.For arch reconstruction during the operation, the ductus arteriosus was divided and the posterior arch was clipped doubly using lt300 titanium ligaclips (ethicon) and divided at its aortic end, allowing it to retract.After elective mechanical ventilation, the patient's trachea was extubated on the fourth postoperative day.Within 6 hours, the patient was reintubated because of respiratory failure primarily due to stridor.After 3 days of further mechanical ventilation, the patient's trachea was extubated a second time.The patient continued to have stridor during both inspiration and expiration and had repeated episodes of desaturation and apnea.The patient's trachea was reintubated for a third time.Computed tomography (ct) scan for evaluation of stridor demonstrated distal tracheal stenosis in close relation to the surgical clips that were applied during separation of the artery arising from the descending aorta and connecting to the right subclavian artery.A right lateral thoracotomy was performed and, although the clips were the cause of tracheal obstruction, the vessel also was traced upward toward the thoracic inlet, and the whole segment was excised in addition to removal of the clips.Subsequent recovery was uneventful, and the patient's trachea finally was extubated after 48 hours of mechanical ventilation.The patient was discharged home 31 days after the first surgery.In this case report, recourse to surgical correction was taken as the ct scan clearly showed that the clip was causing the tracheal stenosis.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9549246
• MDR Text Key: 188494425
• Report Number: 3005075853-2020-00067
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012825
• UDI-Public: 10705036012825
• Combination Product (y/n): N
• Reporter Country Code: MU
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LT300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention