MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196501022

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Laceration(s) (1946); Pain (1994); Urinary Retention (2119); Blood Loss (2597)

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.

Event Description

According to the available information, a clinical abstract stated two patients had a vaginal wall laceration, detected intraoperatively, requiring repair of the vaginal wall and formation of a deeper subcutaneous path for the placement of a new mesh.Both women were prescribed topical estrogens for the first postoperative month.In one of them, vaginal extrusion had endured at first month follow-up consultation, and surgical excision of the eroded mesh was completed; this patient was considered a treatment failure.Regarding the patients with vaginal exposure of the tension adjustment thread (and without extrusion of the mesh), the thread was cut short in the office setting; both patients were prescribed topical estrogens with no later recurrence.The 2 patients with transient urinary retention on the first postoperative day required the placement of an indwelling catheter; 1 week later, a voiding trial was repeated and both had a post-void residual urine volume, without the need for further intervention.Minor changes in the urinary stream were described by 10 of the women.Dyspareunia was encountered in some patients in the first follow-up consultations; most cases were resolved with topical estrogen therapy.Two women maintained mild dyspareunia at 12 months' follow-up, a rate comparable to those of other sling procedures.Contraction or shrinkage of the tape was not found on physical examination and this minor complaint may be justified by the more superficial, sub mucosal path of the sling.3 cases of postoperative exposure of the adjustment thread, resolved with minimal intervention in the office setting.Treatment failure at 12 months' follow up stated 2 patients experienced mixed sui and oab symptoms, 1 patient experienced isolated oab symptoms, 1 experienced vaginal mesh erosion, and 1 experienced pure sui symptoms.Post operative complications noted 1 patient with vaginal bleeding, 5 patients with urinary tract infection, 3 patients with de novo urgency, 7 patients with overactive bladder.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 7885127
• MDR Text Key: 120554928
• Report Number: 2125050-2018-00694
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196501022
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other