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

Catalog Number ERXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067); Skin Discoloration (2074)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/29/2023.D4: batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article?" this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via journal article: title: the ¿nick¿ or ¿clip¿? a giant hepatic artery pseudoaneurysm complicating laparoscopic cholecystectomy.Authors: ramanuj mukherjee, shouptik basu.Citation: j min access surg 2022;18:148-50.Doi: 10.4103/jmas.Jmas_71_21.This study reports a case of an unmarried 26-year-old thin built (57 kg; body mass index 20.2) female who underwent laparoscopic cholecystectomy using metallic ligaclip®.Reported complications include ruptured right hepatic artery pseudoaneurysm (hapa) after 4 weeks post-operatively which presents with a lump in the right upper quadrant of her abdomen and two episodes of malaena.Clinical examination revealed that she was pale, anicteric, with a pulse rate of 120/min, blood pressure of 90/60 mm of hg, respiratory rate of 25/min, and a tender lump in the right upper quadrant, raised a probable suspicion of an infected bilioma in a postcholecystectomy setting.There were no symptoms suggestive of hepatic failure.However, despite aggressive resuscitation in line with sepsis management, the patient developed progressive pallor, hypotension and further episodes of malena over a span of 8 hours.Laboratory results showed a haemoglobin of 5.6 g/dl, slightly elevated hepatic enzymes with a normal coagulation profile.She was resuscitated with iv fluids and packed red blood cells were transfused.Despite best efforts of resuscitation in the intensive care unit, the patient gradually deteriorated, and an urgent unavailability of angio-embolisation warranted an urgent exploratory laparotomy.The abdomen was accessed with a right subcostal incision.The subphrenic and supracolic compartments containing altered clotted blood were evacuated.The right hepatic artery was isolated, controlled proximally, and the ruptured pseudoaneurysmal sac was opened with minimal back bleeding and excised [figure 2a].The pseudoanerysm sac was identified in relation to cystic artery stump with a metal clip (ligaclip®) eroding in the right hepatic artery.The rent in the wall of the right hepatic artery was repaired after refashioning of the edges [figure 2b].No other associated visceral injuries were present.The arterial anatomy showed the most common prevalent pattern with a single right hepatic artery arising from trunk of common hepatic 5 cm after gastroduodenal artery branch.The pathology of the site did not allow to comment of ¿moynihan hump/caterpillar hump¿ of short tortuous cystic artery/right hepatic artery.No active bile leak from cystic duct stump (ligated again) or liver bed was identified.Peritoneal lavage was given, and a wide bore drain was kept in the morrison¿s pouch.Haemostasis was achieved, and the wound was closed in two layers.The patient received 3 units of packed red blood cells postoperatively, and the post-operative course was uneventful except occurrence of superficial surgical site infection which needed wound dressings.She was discharged on day 12 following her surgery.On follow-up as outpatient at 6 months, she did not reveal signs of delayed biliary stricture or liver dysfunction.Ultrasound and doppler assessment at hepatic hilum revealed a bidirectional flow.In conclusion, being a rare clinical entity, hapa has a predilection to be missed.A high index of suspicion is essential, and prompt management is the key to managing such patients because they can suddenly deteriorate due to exsanguination.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17844819
• MDR Text Key: 324606254
• Report Number: 3005075853-2023-07023
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 57 KG