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 Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Journal article had publication year of 2008.This report is related to a journal article; therefore, no product will be returned for analysis.As the device was not returned, an analysis investigation could not be performed.The lot/ batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that during the review of a journal article, title: long-term outcomes of living donor kidney transplants in pediatric recipients following laparoscopic vs.Open donor nephrectomy.Author(s): lyubov chaykovska, serdar deger, jan roigas, andre lenz, poline lioudmer, lisa t.Kothmann, frank friedersdorff, dominik muller, antje kasper, markus giessing, ahmed magheli, carsten kempkensteffen, anja lingnau and t.Florian fuller; citation: https://doi.Org/10.1111/petr.12008.The purpose of this retrospective single-center study was to compare long-term outcomes of live donor kidney transplantation (ldkt) in pediatric recipients following either laparoscopic donor nephrectomy (ldn) or open donor nephrectomy (odn).Between january 1989 and february 2011, a total of 55 patients underwent ldkt.Long-term outcomes were compared in two groups: [n=38 (n=22 female, n=16 male, median age 41 years (24¿67 years)] children who received an ldkt after laparoscopic donor nephrectomy; and with outcomes of [n=17 (n=15 female, n=2 male, median age 38 years (24¿48 years)] children who received an ldkt after odn.In ldn group, to prevent dislodgement of the hem-o-lok clip and to preserve an arterial stump of sufficient length, an additional 12-mm titanium clip (ethicon) was used.Postoperative complication included bleeding (n=1) which required laparoscopic revision.In ldkt for pediatric recipients, ldn is a safe and efficient alternative to odn, providing excellent long-term graft outcomes.The safety and success of ldn for pediatric recipients is mainly determined by center experience.Renal artery multiplicity may cause early allograft dysfunction in pediatric ldkt recipients.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10103294
• MDR Text Key: 196780826
• Report Number: 3005075853-2020-02756
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention