MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Granuloma (1876); Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Seroma (2069); Urinary Retention (2119); Urinary Tract Infection (2120); Swelling/ Edema (4577)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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 number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Events were submitted via 2210968-2021-09799.Citation: https://doi.Org/10.1016/j.Urology.2020.05.068.

Event Description

Title: iliac fossa muscle splitting incision in laparoscopic donor nephrectomy: a comparison with the suprapubic approach.This study aimed to compare donor and recipient outcomes after these 2 different kidney retrieval incisions.A total of 70 patients (n=35 via spm incision ; n=35 an ifms incision) undergoing live donor nephrectomy between december 2016 to february 2019 at a single center were included in the study.An open technique was used to access the peritoneal cavity and a pneumoperitoneum was established and maintained at 12-15 mmhg.Three ports were used, a 12 mm camera port placed above and slightly lateral to the umbilicus, a 12 mm operating port placed in the ipsilateral iliac fossa, and a 5 mm operating port placed in the epigastrium.The colon was mobilized, and the ureter and gonadal vein were identified at the pelvic brim.The gonadal vein was followed superiorly to identify the renal vein.Adrenal, gonadal, and posterior lumbar venous tributaries were divided.The renal artery was dissected to its origin from the aorta.All lateral and posterior attachments of the kidney were freed.All retrieval incisions were marked preoperatively to a measured length of 6 cm.Spm incisions were placed 1 cm above the pubic symphysis.After division of the skin and subcutaneous fat, the peritoneum was accessed via a midline incision through the linea alba.Ifms incisions were placed below and lateral to the 12 mm iliac fossa operating port and at the level of, or inferior to, the anterior superior iliac spine.The skin and subcutaneous fat were divided transversely over a 6 cm measured length.The external oblique muscle/aponeurosis, the internal oblique, and transversus abdominis muscles were then split in the line of their fibers to expose the peritoneum.The peritoneum was controlled with a 2/0 vicryl purse-string suture and an endocatch ii retrieval system (covidien, mansfield, massachusetts) was inserted into the abdomen through the peritoneum.The ureter was divided after securing the distal end with 2 weck hem-o-lok clips (teleflex, morrisville, north carolina).The renal artery and vein were divided using a linear stapler cutter (ethicon inc., bridgewater, new jersey).The kidney was removed in the endocatch bag.Retrieval incisions were closed with no.1 pds or no.1 polypropylene.A long acting la such bupivacaine was infiltrated during wound and port site closure using different volumes, strengths (0.25% or 0.5%) with or without adrenaline based on patient¿s weight and operating surgeon¿s preference.All patients were managed postoperatively using a pca morphine system and later in their recovery with oral analgesia.The hyperkalemia was treated by the anesthetist and the procedure was abandoned.However, the laparoscopic ports had been inserted and extensive mobilization had taken place, including division of the adrenal vein.Nephrectomy was not performed, and the patient recovered without the need for dialysis.The patient was included as part of the intention to treat analysis.Postoperative complications included n=1 acute urinary retention, n=1 seroma, n=2 stitch granuloma, n=2 surgical site infection, n=3 urinary tract infection, n=2 hematoma in resection bed, n=1 scrotal swelling, n=1 hyperkalemia, and n=1 rhabdomyolysis secondary to pressure necrosis during surgery.In conclusion, a transverse iliac fossa muscle splitting incision is a reasonable alternative to the more traditional and widely used suprapubic incision for kidney retrieval during laparoscopic donor nephrectomy, without additional pain or adverse outcomes for donors and recipients.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6.Health effect - impact code: f07 - hyperkalemia.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.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12647250
• MDR Text Key: 276916351
• Report Number: 2210968-2021-09800
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N18331
• 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,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2022
• 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