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

Catalog Number ERXXX

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/18/2018.Batch # unknown.As a lot/batch was not provided, a device history could not be performed.

Event Description

It was reported via journal article: title: endoclip migration into the common bile duct with stone formation: a rare complication after laparoscopic cholecystectomy.Authors: sukanta ray, ms, mch, sankar prasad bhattacharya, ms.Citation: jsls.2013; 17: 330¿332.Doi: 10.4293/108680813x13654754534350.A (b)(6) male presented with recurrent upper abdominal pain and intermittent jaundice for 6 months.Six years ago, the patient underwent lc for an acute calculus cholecystitis.During the procedure, dissection of the calot¿s triangle was difficult, and the cystic duct was wide and edematous.The cystic duct was controlled with large size ligaclip 400 endoclip (ethicon).Ultrasound of the abdomen showed a dilated extrahepatic biliary tree to the lower end.An abdominal computed tomography (ct) scan showed a dilated bile duct with a small radio-opaque metal density in the distal common bile duct.Magnetic resonance cholangiopancreatography (mrcp) showed a dilated common bile duct with a low signal filling defect in the distal common bile duct.An endoscopic retrograde cholangiopancreatography (ercp) was performed and showed a single filling defect in the common bile duct with metallic density (ligaclip endoclip) at the center of the filling defect.A sphincterotomy was performed.The stone and 2 ligaclip endoclips were successfully removed from the bile duct.The patient had an uneventful recovery and was well at 3 months follow-up.It was reported that clip migration is more common when lc is done for acute cholecystitis.Here, the cystic duct was wide and edematous, making effective closure difficult with a ligaclip endoclip.Moreover, excessive pressure by the clip applicator may have caused a cheese-wire effect and necrosis of the cystic duct stump.In this case, cholecystectomy in the setting of acute cholecystitis with ineffective closure of the cystic duct leading to bile leak and local infective processes may have been the possible mechanism of clip migration.Although rare, clip migration with biliary complications needs to be considered in the differential diagnosis of patients presenting with post-cholecystectomy problems.The clinical manifestations of clip migration are similar to that of non-iatrogenic choledocholithiasis, and ercp is currently the treatment of choice.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7886134
• MDR Text Key: 120595561
• Report Number: 3005075853-2018-12841
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ERXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1