MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC

Model Number PCO3728X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Calcium Deposits/Calcification (1758); Edema (1820); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Scarring (2061); Swelling (2091); Tachycardia (2095); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic laparoscopic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced pain, bowel obstruction, adhesions,and recurrence.Post-operative patient treatment included revision surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic laparoscopic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced pain, adhesions, open wound, mesh erosion into viscera, small bowel obstruction, foreign body giant cell reaction, hemosiderin deposition, dystrophic calcifications, ischemia, leukocytosis, vascular congestion, edema, necrosis, inflammation, hemorrhages, fibrosis, abscess, serositis, po (by mouth/oral intolerance, tenderness, distention, abdominal pain, constipation, discomfort, nausea, tachycarida, wasn't passing gas, loss of domain, devascularized bowel, hypotensive, fever, abdomen basically becoming a syncytium, swelling, scarring, fistula, and recurrence.Post-operative patient treatment included revision surgery, hernia repair with implantation of new mesh, bowel resection, reopening of abdomen by removal of temporary abdominal dressing, abdomen washout, dissection of adhesions, wound vac, hospitalization, nasogastric tube placed, antibiotics, enterolysis, enterorrhaphy, enterotomy, temporary closure of abdomen and small bowel, debridement of abdominalwall, reopening and release of recent laparotomy, stoma, tracheostomy, r femoral trialysis catheter placement, malecot drain placed, non-tunneled perm cath l ij (internal jugular) placed, r fem catheter removed, split thickness skin grafting to abdominal wall wound, r brachial picc line insertion, resuscitation, and mesh removal.

Manufacturer Narrative

Additional b2, b5, b6, b7, d11, h6.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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic laparoscopic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced pain, adhesions, open wound, mesh erosion into viscera, small bowel obstruction, and recurrence.Post-operative patient treatment included revision surgery, hernia repair with implantation of new mesh, bowel resection, reopening of abdomen by removal of temporary abdominal dressing, abdomen washout, dissection of adhesions, wound vac, and mesh removal.

Manufacturer Narrative

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: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9668097
• MDR Text Key: 177745607
• Report Number: 9615742-2020-00330
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179653
• UDI-Public: 10884521179653
• Combination Product (y/n): N
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: PCO3728X
• Device Catalogue Number: PCO3728X
• Device Lot Number: PME00448
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN TACKER; UNKNOWN TACKER (UNKOWN LOT NUMBER)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 138