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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIS TRANS-OBTURATOR KIT; SURGICAL MESH
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ARIS TRANS-OBTURATOR KIT; SURGICAL MESH Back to Search Results
Model Number 5195512400
Device Problems Device Appears to Trigger Rejection (1524); Material Deformation (2976); Insufficient Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Abdominal Pain (1685); Erosion (1750); Edema (1820); Foreign Body Reaction (1868); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Discharge (2225); Injury (2348); Depression (2361); Impaired Healing (2378); Blood Loss (2597); Nervous System Injury (2689); No Information (3190); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This mdr is created as a follow-up to record (b)(6), initially reported on product code otn asr exemption # e2014015 for oct-november 2016.This mdr is to reflect the additional information to be added to the initial asr report.(patient age and product information).A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
 
Event Description
This mdr is created as a follow-up to record (b)(6), initially reported on product code otn asr exemption # e2014015 for october-november 2016.This mdr is to reflect the additional information to be added to the intial asr report.
 
Manufacturer Narrative
This follow-up was created to document the additional event information received and updated, corrected h6 codes.Patient code 3191 used for pulling in the vagina.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
As reported to coloplast though not verified, patient's legal representative stated unmeasured area of extruded aris in the midline incisional area, redundant area of aris had dropped down and folded over on itself and herniated out of the midline incision site, this then caused breakdown of the incisional area and vaginal atrophy, vaginal bleeding - concern that claimant was noncompliant with post-operative instructions and was active, excision size measured an approximate 1 cm, unmeasured extruded/exposed aris in the midline incisional area that would not heal, continued unmeasured extrusion of aris in the midline incisional area, complete extrusion/adhesion of left arm of aris, unmeasured extrusion of aris out of right vaginal side wall, aris very loose and protruding underneath flap tissue secondary to significant edema/inflammation, pelvic/perineal pain, pulling sensation in groin all the way toward the obturator membrane, palpation reproduced the pain up to the insertion point of aris, thin wall over left arm of aris - conclusion that claimant's body was not tolerant to having the foreign object in her body.Additional information stated, (b)(6) 2016 - suture was hanging loose and was removed.Mesh extrusion on the left side of mid urethra.Patient used premarin cream.Approximately 1cm of mesh excised on (b)(6) 2016.On (b)(6) 2016- vaginal exploration, partial removal of exposed sling mesh and complex vaginal closure for no-healing vaginal tissue with extrusion of the vaginal mesh under general anesthesia.A few months later patient complained of dyspareunia and a pulling in the vagina.Physician injected lidocaine along the course of the sling to help with the pain.(b)(6) 2016- cystoscopy, excision of sling, vaginal exploration, difficult dissection especially on the left for pelvic pain and sling extrusion under general anesthesia.Surgical findings showed swollen, inflamed vaginal tissue and extruded mesh coming off the right vaginal sidewall.Noted it was very difficult to find adhered mesh arm on the left.Surgical pathology showed surgical mesh with associated soft tissue showing chronic inflammation and foreign body giant cell type reaction.Underwent macroplastique transurethral bulking injection with cystoscopy under intravenous sedation.
 
Manufacturer Narrative
Patient code 3190 was selected for "repair pelvic organs".Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
Additional information, as reported to coloplast though not verified, indicated severe pain with daily activities and intercourse requiring additional medical care and a removal procedure, injuries, infections, pain, discharge, multiple corrective surgeries, operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia, urinary incontinence.
 
Event Description
This follow-up mdr is created to document the additional event information received for record #(b)(4) reports continued health issues, including bladder issues and recent surgery in may for it contributed to her depression; pelvic, perineal and abdominal pain.
 
Manufacturer Narrative
According to the available information the patient's legal representative stated unmeasured area of extruded aris in the midline incisional area, redundant area of aris had dropped down and folded over on itself and herniated out of the midline incision site, this then caused breakdown of the incisional area and vaginal atrophy, vaginal bleeding - concern that claimant was noncomplaint with post-operative instructions and was active, excision size measured an approximate 1 cm, unmeasured extruded/exposed aris in the midline incisional area that would not heal, continued unmeasured extrusion of aris in the midline incisional area, complete extrusion/adhesion of left arm of aris, unmeasured extrusion of aris out of right vaginal side wall, aris very loose and protruding underneath flap tissue secondary to significant edema/inflammation, pelvic/perineal pain, pulling sensation in groin all the way toward the obturator membrane, palpation reproduced the pain up to the insertion point of aris, thin wall over left arm of aris.Conclusion that claimant's body was not tolerant to having the foreign object in her body.Aris was implanted on (b)(6) 2015 and removed on (b)(6) 2016.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to the reported complaints are captured in the product risk documentation.Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
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Brand Name
ARIS TRANS-OBTURATOR KIT
Type of Device
SURGICAL MESH
MDR Report Key9716803
MDR Text Key190008488
Report Number2125050-2020-00152
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number5195512400
Device Catalogue Number519551
Device Lot Number4878685
Patient Sequence Number1
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