MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN PROTACK

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

Patient Problems Hernia (2240); Unintended Radiation Exposure (4565)

Event Date 05/05/2023

Event Type  Injury  

Event Description

According to the literature, a retrospective study analyzed patient-related factors that may influence the risk of hernia recurrence in patients who underwent elective laparoscopic incisional hernia mesh repair between september 2002 and september 2017.The intraperitoneal onlay mesh technique was performed and fixed with tackers or other competitor devices.There were 312 patients in the study.Hernia recurrence developed in 39 patients, of which 18 occurred with use of a partially absorbable mesh was used and that has been taken off the market due to a high recurrence rate.Hernia recurrence was diagnosed with parietal ultrasound or abdominal computed tomography scanning and 15 patients underwent reoperation to resolve the issue.Predictors of recurrence are related to: obesity, recurrent hernias, and defect size >10 cm, mesh type, fixation technique, and overlapping in the surgical defect.Other complications that were not related to the device include: intraoperative intestinal perforation, postoperative bleeding of the hepatic ligament and death due to sepsis following cholecystitis.

Manufacturer Narrative

D10 concomitant products: unknown parietene, unknown parietene mesh product (lot#unknown) unkabstack, unknown absorbatack (lot#unknown) reference: giorgio soliani, 2023, predictive factors of recurrence after laparoscopic incisional hernia repair: a retrospective multicentre coh ort study, journal of laparoendoscopic &advanced surgical techniques, volume 33, number 5, ª mary ann liebert, inc.Doi: 10.1089/lap.2022.0465 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17636757
• MDR Text Key: 322108317
• Report Number: 2647580-2023-03667
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROTACK
• Device Catalogue Number: UNKNOWN PROTACK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Female