MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Positioning Problem (3009)

Patient Problems Abscess (1690); Hematoma (1884); Seroma (2069); Abnormal Vaginal Discharge (2123); Hernia (2240); Post Operative Wound Infection (2446); 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.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Citation: dis colon rectum.2017; 60: 178 186.Doi: 10.1097/dcr.0000000000000710.(b)(4).

Event Description

It was reported in journal article: ¿title: risk factors for recurrence after laparoscopic ventral rectopexy¿ authors: cherylin w.P.Fu, m.B.B.S, m.Med, f.R.C.S.Ed; andrew r.L.Stevenson, m.B.B.S, f.R.A.C.S citation: dis colon rectum.2017; 60: 178 186.Doi: 10.1097/dcr.0000000000000710.The objectives of this retrospective cohort study aimed to evaluate factors contributing to recurrence after laparoscopic ventral rectopexy (lvr).A total of 231 patients underwent lvr and were included in the study.All of the procedures were performed by or under the direct supervision of a single surgeon experienced in the lvr technique.The procedure was fully laparoscopic, and either a synthetic mesh or a biologic graft was used.The method of fixation of the graft to the sacral promontory used was pds sutures in 41 patients and the type of mesh used were prolene and ultrapro synthetic mesh in 32 patients.It was also noted that modifications to the technique evolved throughout the study period.Reported complications included pelvic abscess which required laparoscopic wash-out, rectovaginal seroma/hematoma, vaginal discharge, wound hernia, wound infection, and recurrent prolapse which required redo lvr, sutured transanal mucosectomy and plication, sacral nerve modulation, ligation of hemorrhoids, stoma, and prosthetic sphincter augmentation.It was reported that the authors identified certain technical aspects of lvr that can contribute to failure and recurrent prolapse: inadequate apposition of the mesh/graft to the lateral and anterior surfaces of the rectum, especially at the midrectum, resulting in inadequate rectal suspension and recurrent internal prolapse or rectoanal intussusception, slippage of mesh attachment from the sacral promontory, which may be attributed to excessive tension on the mesh or poor anchoring technique to the sacral promontory, and the distal part of the mesh/graft being too narrow, resulting in inadequate support of the lateral aspects of the rectum and pelvic floor.It was concluded that recurrent prolapse after lvr is multifactorial and risk factors are both clinical and technical.The use of biologic grafts was associated with lower recurrence as compared with synthetic mesh.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: none of the recurrences were related to ethicon products.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7396533
• MDR Text Key: 104367403
• Report Number: 2210968-2018-71877
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2018
• 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