MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number UNKNOWN - SUTUR

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Discharge (2225); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Title erosion after laparoscopic ventral mesh rectopexy with a biological mesh.Source techniques in coloproctology.21 (12) (pp 985-986), 2017.Date of publication: 01 dec 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, there was an erosion after a laparoscopic ventral mesh rectopexy(lvmr) with a biological mesh.We present a case of erosion that occurred 23 months after lvmr using a biological mesh.Briefly, a (b)(6)-year old female underwent lvmr, 7 years after a industry performed for external full-thickness rectal prolapse.She presented with a grade v rectal prolapse.Lvmr was performed with the use of strip of biological mesh.After 23 months, the patient experienced discharge of mucous and pus through the anus with no associated symptoms.A flexible colonoscopy was performed which revealed a sinus on the anterior wall of the rectum containing a suture previously used for the mesh fixation to the rectum.The suture was removed in the same sitting.It is likely that surgical technical errors, such as unrecognized rectal or vaginal injury or excessively deep placement of fixation sutures, may be responsible for such erosion.Nonetheless, this suture erosion could be avoided by the use of absorbable sutures such as polydioxanone (pds) instead of non-absorbable sutures in a consensus on ventral mesh rectopexy.In conclusion, erosions after use of biological mesh are very rare and could be attributed to non-absorbable sutures which may create a sinus secondary to a chronic inflammatory reaction with a number of patients presenting with erosions within a short time after surgery.This could be avoided by the use of pds sutures.Erosion after laparoscopic ventral mesh rectopexy with a biological mesh.

• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7324830
• MDR Text Key: 101953001
• Report Number: 1219930-2018-01387
• Device Sequence Number: 1
• Product Code: GAM
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN - SUTUR
• Device Catalogue Number: UNKNOWN - SUTUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR