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

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Renal Failure (2041); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 04/26/2021

Event Type  Injury  

Event Description

Title: interrupted sutures prevent recurrent abdominal fascial dehiscence: a comparative retrospective single center cohort analysis of risk factors of burst abdomen and its recurrence as well as surgical repair techniques the aim of this study was to find out the risk factors for ba and its recurrence and if a certain suturing technique or the implantation of meshes would prevent burst abdomen recurrence (bar).In this study, the surgeons report the results for the time span from 2015 to 2018 of our retrospective cohort.All median laparotomies are closed with 2 looped number 1 pds sutures (ethicon, johnson&johnson, (b)(4)) in a mass suturing technique.Oblique incisions are closed with two separate running pds sutures for anterior and posterior rectus sheath.Ba is diagnosed clinically during wound inspection on the surgical ward or occasionally during revision laparotomy.Generally, a thorough exploration of the abdominal cavity is performed during revision surgery to check for intra-abdominal pathologies or other underlying causes for ba.Depending on the fascial quality, the fascial defect will be closed either with continuous looped number 1 pds or interrupted number 2 vicryl sutures (ethicon, johnson&johnson, (b)(4) according to the surgeon¿s discretion.If the fascial quality seems insufficient for primary fascial closure or would be closed with tension, a vicryl mesh can be placed in ipom position before the fascia is closed.If closure of the fascial defect is impossible due to extensive fascial necrosis or intestinal edema, a vicryl mesh (ethicon) will be placed in the inlay position to prevent evisceration and, subsequently, a v.A.C.Dressing will be installed to create a laparostomy.Reported complications included delerium (n=7), bleeding (n=6), acute renal failure (n=35), enteroatmospheric fistula (n=2) , death (n=4) in conclusion the use of interrupted sutures together with the implantation of an intraabdominal mesh in burst abdomen repair helps to reduce bar and the need for additional revision surgeries.

Manufacturer Narrative

Product complaint # (b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2021-11297, 2210968-2021-11298, 2210968-2021-11299, 2210968-2021-11300, 2210968-2021-11301.Citation cite: mehdorn et al.Bmc surg (2021) 21:208 https://doi.Org/10.1186/s12893-021-01219-x.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12798984
• MDR Text Key: 285228328
• Report Number: 2210968-2021-11296
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention