MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL; MESH, SURGICAL

Model Number P101010

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

Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Scarring (2061); Hernia (2240); Injury (2348)

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 treatment of a hernia.It was reported that after implant, the patient experienced a pocket of purulence opened which was spread significantly.The purulence was found to go behind the mesh on the posterior aspect and somewhat on the anterior aspect.On the posterior aspect it was reaching over to the contralateral side to the left side of the esophagus.It was clear that the infectious cavity built a rind and this rind was also going to bilateral crura going to the hiatus involving the posterior stitches at the previous fundoplication.Laparoscopic redo hiatal hernia repair.In the abdomen there are significant adhesions found from the wrap to the undersurface of the left lower lobe which were carefully lysed.Post-operative patient treatment included revision surgery.

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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a symptomatic para esophageal hernia.It was reported that after implant, the patient experienced a pocket of purulence opened which was spread significantly.The purulence was found to go behind the mesh on the posterior aspect and somewhat on the anterior aspect.On the posterior aspect it was reaching over to the contralateral side to the left side of the esophagus.It was clear that the infectious cavity built a rind and this rind was also going to bilateral crura going to the hiatus involving the posterior stitches at the previous fundoplication.Laparoscopic redo hiatal hernia repair.In the abdomen there are significant adhesions found from the wrap to the undersurface of the left lower lobe which were carefully lysed.Post-operative patient treatment included revision surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a symptomatic paraesophageal hernia.It was reported that after implant, the patient experienced a pocket of purulence opened which was spread significantly, recurrence, the purulence was found to go behind the mesh on the posterior aspect and somewhat on the anterior aspect on the posterior aspect it was reaching over to the contralateral side to the left side of the esophagus.It was clear that the infectious cavity built a rind and this rind was also going to bilateral crura going to the hiatus involving the posterior stitches at the previous fundoplication.In the abdomen there are significant adhesions found from the wrap to the undersurface of the left lower lobe.Post-operative patient treatment included laparoscopic redo hiatal hernia repair, redo nissen fundoplication, and lysis of adhesions.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt.  due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.Additional information: a4(weight in lbs), b5, b7, d1, d7, g4, 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.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 laparoscopic therapeutic treatment of a symptomatic paraesophageal hernia.It was reported that after implant, the patient experienced purulence, recurrence, adhesions and scar tissue.It was clear that the infectious cavity built a rind and this rind was also going to bilateral crura going to the hiatus involving the posterior stitches at the previous fundoplication.In the abdomen there are significant adhesions found from the wrap to the undersurface of the left lower lobe.Post-operative patient treatment included laparoscopic redo hiatal hernia repair, redo nissen fundoplication, and lysis of adhesions.

• Brand Name: PERMACOL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• MDR Report Key: 8458590
• MDR Text Key: 140123999
• Report Number: 9617613-2019-00025
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2015
• Device Model Number: P101010
• Device Catalogue Number: P101010
• Device Lot Number: 11B1506
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 63