MAUDE Adverse Event Report: ETHICON INC. SECURESTRAP UNKNOWN PRODUCT; IMPLANTABLE STAPLE

Device Problem Defective Component (2292)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Hernia (2240)

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that 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 the ethicon products used in this procedure? citation: langenbeck's archives of surgery.Doi: https://doi.Org/10.1007/s00423-018-1676-z.(b)(4).

Event Description

It was reported in a journal article title: effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue.The method of anchoring the mesh in laparoscopic ventral hernia repair is claimed to cause postoperative pain, affecting the quality of life (qol) of the patients.The aim of this randomized study was to compare the effect of three types of fixation devices on postoperative pain, patient quality of life, and hernia recurrence.A total of 75 patients with ventral hernias between 2 and 7 cm were randomized into one of three mesh fixation groups: permanent tacks (25 patients; 18 male and 7 female patients; age range: 58.1 ± 11.2; bmi: 29.9 ± 3.8), absorbable tacks (securestrap; 25 patients; 15 male and 10 female patients; age range: 60.2 ± 10.8; bmi: 28.8 ± 4.0), and absorbable synthetic glue (25 patients; 21 male and 4 female patients; age range: 56.7 ± 9.8; bmi: 29.2 ± 3.8) and were included in the study.During the surgical procedure, a physiomesh mesh (ethicon) laminated with resorbable monocryl sutures (ethicon) on both sides were used in all groups.The anchoring devices used were permanent tacks, securestrap absorbable tacks (ethicon), and absorbable synthetic glue.Before introducing the mesh to the abdominal cavity, a sterile template was placed over the mesh.The fixation points were marked according to the double crown technique, ensuring the same number and placement of fixation points in all patients.The mesh was placed bridging the defect and anchored to the abdominal wall with the allocated device.All patients received a 15 cm × 15 cm mesh regardless of the size of the defect, providing an overlap of 4 to 6.5 cm, depending on the size of the fascial defect.At 1 month follow-up in the permanent tacks group, reported complications included infection presenting as redness or discharge of pus at the port site (n-5) in which the infection was self-limiting in 3 patients.Four patients received oral antibiotics; 3 of 4 patients had infections with purulent discharge.The infection progressed in 1 patient who was affected with purulent discharge, and the mesh had to be removed 2 months after surgery, clinically diagnosed seroma (n-9) which resolved spontaneously, mesh sensation reported as bothersome (n-2), and pain (n-3).At 1 month follow-up in the absorbable tacks group, reported complications included infection presenting as redness or discharge of pus at the port site (n-1), clinically diagnosed seroma (n-11) which resolved spontaneously, mesh sensation reported as bothersome (n-3), and pain (n-4).At 1 month follow-up in the absorbable synthetic glue group, reported complications included infection presenting as redness or discharge of pus at the port site (n-1), clinically diagnosed seroma (n-11) which resolved spontaneously, mesh sensation reported as bothersome (n-3), and pain (n-5).At 6 months follow-up in the permanent tacks group, reported complications included recurrence (n-1).At 6 months follow-up in the absorbable tacks group, reported complications included recurrence (n-1).At 12 months follow-up in the permanent tacks group, reported complications included recurrence (n-2).At 12 months follow-up in the absorbable tacks group, reported complications included recurrence (n-1).In conclusion, the present randomized trial in patients undergoing lvhr of small- and medium-sized ventral hernias with a follow-up of 12 months did not show significant differences between permanent tacking, absorbable tacking, and glue fixation of mesh with regard to pain as the primary endpoint or in qol or recurrence rate as secondary endpoints.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.

• Brand Name: SECURESTRAP UNKNOWN PRODUCT
• Type of Device: IMPLANTABLE STAPLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7815652
• MDR Text Key: 118212753
• Report Number: 2210968-2018-75427
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K093845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 08/29/2018
• 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