MAUDE Adverse Event Report: ABISS - ANALYTIC BIOSURGICAL SOLUTIONS ARIS TRANSOBTURATOR SLING; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.The item number and lot number is not known.Caramazza d, campagna g, moro f, vacca l, marturano m, pizzacalla s, trivellizzi in, panico g, scambia g, ercoli a, testa ac.Transobturator tape versus single incision sling: how are they different? clinical outcomes and ultrasonographic features of two mid-urethral slings.World j urol.2022 oct;40(10):2521-2528.Doi: 10.1007/s00345-022-04109-w.Epub 2022 aug 18.Pmid: (b)(6).

Event Description

Title: transobturatory tape versus single incision midurethral sling: clinical outcomes and ultrasonographic aspects of two surgical techniques.Study outcomes: primary outcome is to compare two surgical techniques for stress urinary incontinence, in terms of post-operative ultrasonographic differences between the two approaches.Secondary outcome is to assess whether there is any correlation between ultrasonographic findings and clinical aspects in operated patients.Materials and methods: this is a retrospective observational study.All patients referring to a third level center for sui and candidate to sui surgery were enrolled.They underwent trans-obturatory tape (tot) or single incision mid-urethral sling (mini-sling) according to international guidelines and surgeon's choice.They were postoperatively assessed, at one month and three months after surgery, with a complete uro-gynecological examination including the assessment of q-tip and a stress test (with empty, 200 ml and 400 ml filled bladder).Transvaginal 2d/3d ultrasound scan, which allowed to fulfil a 3d reconstruction of the sling in the trans-obturator space, was performed using a bk medical biplane probe.We analyzed together with clinical uro-gynecological parameters the following ultrasonographic indexes: sling-pubis gap, distance between sling and bladder neck, angle between the branches of the sling, distance from urethral lumen and the presence of shrinkage.A new evaluation of qol was performed by means of iciq-sf questionnaire.Patients could express their subjective impression of improvement (pgi-i validated score).Results: a total of 61 patients underwent sui surgery from january 2018 to october 2019: 22 tot and 39 mini-sling were performed.Reported data are related to one-month and three months follow up examination.There were no significant differences between the two techniques in terms of cure rate but a significant difference was found in the pgi-i after one month in favor of mini-sling (p=0.016).Mini-slings require significant lower operative time (p= 0.005) and were associated with lower rate of postoperative pain after one month (p=0.008).Mini-sling seem to have narrower angle between the branches (p=0.000 and p=0.000 respectively after one and three months), a higher distance from lumen of urethra (p=0.000 and p=0.001 respectively) and higher distance from the bladder neck (p=0.005), furthermore mini-sling were more often positioned exactly in the middle urethral point (p=0.005 respectively).There was an inverse correlation after one and three months between q-tip test and angle between the branches (p=0.059 pearson's rho -0.578 and p=0.005, pearson's rho -0.534);moreover, a correlation was found between pgi-i and angle of the branches after three months (p=0.009, pearson's rho 0.503) [figure 1].At three months follow up, vaginal erosion was observed only in two cases of tot group: correlation with shrinkage (pearson's rho 0.46, p=0.016) and with distance from bladder neck (pearson's rho -0.46, p=0.016) was observed.Conclusions: tot and mini-sling are both safe and effective with high cure rate and low postoperative complications, even though mini-sling seem to have a shorter operative time and less postoperative groin pain, with a greater pgi-i.Pelvic floor us allowed us to demonstrate that mini-sling have a narrower angle of the branches and lie at an higher distance from lumen of urethra; the narrower angle, together with the correlation established between angle of the branches and q-tip and pgi-i, could suggest a more lateral compressive effect of mini-sling, which is according to literature related to a greater effectiveness, and thus a greater perception of improvement for the patients.The increased distance from lumen of urethra could be related to a lower incidence of post-operative complications as, for instance, a lower erosion rate but further studies with bigger sample size and a longer follow-up are needed to clarify all the ultrasonographic findings.

• Brand Name: ARIS TRANSOBTURATOR SLING
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): ABISS - ANALYTIC BIOSURGICAL SOLUTIONS; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17927951
• MDR Text Key: 325565165
• Report Number: 2125050-2023-01228
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2023
• 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 Sex: Female