MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT; CLIP, IMPLANTABLE

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

Patient Problems Anemia (1706); Hematoma (1884); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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 were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number? does the surgeon believe that ethicon products (vicryl suture and lapra-ty suture clip) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (vicryl suture and lapra-ty suture clip) involved? patient demographics? citation: urology 132: 130-135, 2019; doi: https://doi.Org/10.1016/j.Urology.2019.05.042.(b)(4).

Event Description

It was reported via journal article: "title: reducing pseudoaneurysm and urine leak after robotic partial nephrectomy: results using the early unclamping technique" author(s): joan c.Delto1, peter chang1, sara hyde, kyle mcanally, catrina crociani, and andrew a.Wagner.Citation: urology 132: 130-135, 2019; doi: https://doi.Org/10.1016/j.Urology.2019.05.042.This single institution retrospective review of a prospectively maintained database aimed to present our experience using the early unclamping technique for robotic partial nephrectomy with particular attention to delayed complications, namely pseudoaneurysm and urine leak.We hypothesized that early hilar unclamping allows for improved control of end arteries and renorrhaphy after tumor resection, reducing overall delayed complications after partial nephrectomy with no increased risk of blood transfusion.From aug2009 to oct2018, 463 patients (n=290 male and n=173 female; mean age of 56.8 years [sd 12 years ranging 19 to 88 years]; mean bmi of 29.7 [sd6.2]) underwent robot-assisted partial nephrectomy using early unclamping technique.In the procedure, the cortical edges are then reapproximated using a standard sliding clip renorrhaphy technique: 0-vicryl suture on a ct-1 needle (ethicon inc), with a hem-o-lok clip (teleflex medical) and lapraty in an interrupted fashion.Postoperative complications included blood loss anemia from a trocar injury to an epigastric vessel (n=1) requiring embolization; retroperitoneal hematoma (n=1) requiring transfusion and embolization; and urine leak (n=1) requiring stent and percutaneous drainage of a urinoma.Additional suturing during renorrhaphy and oversewing of arterial bleeders could potentiate additional vessel injury.We attribute our low pseudoaneurysm rate to shallow and accurate placement of figure-of-eight sutures to control arterial bleeders if present as well as closure of dead space within the renorrhaphy bed, occasionally utilizing an autologous fat bolster for larger defects.The early unclamping technique for robotic partial nephrectomy is reliable and safe, with low pseudoaneurysm and urine leak rates which compare favorably to other published techniques.

• Brand Name: LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9965107
• MDR Text Key: 195895105
• Report Number: 2210968-2020-03065
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• 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