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Received 1 used ajust helical mesh implant with kit components and the original unit packaging.Visual inspection noted that the post had broken off of the adjustable anchor.The broken post was still inside of the collet on one of the helical handles.The handles/introducers were functional with no visible defects observed.Further examination with magnification noted that the tip of the anchor was severely bent/rolled.The appearance of the anchor tip is consistent with the anchor making contact with bone.Based on the tip of the anchor being bent/rolled it is believed that this is user related damage and not due to a malfunction of the product.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "device description: the ajust® helical adjustable single-incision sling system is a minimally invasive suburethral sling intended for the treatment of female stress urinary incontinence.The system consists of an adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, introducers and a flexible stylet for advancing the sling lock after adjustment.The device is terminally sterilized by ethylene oxide.Refer to figure 1 below for a detailed depiction of the ajust® helical sling system components.Indications for use: the ajust® helical adjustable single-incision sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.Contraindications: the ajust® helical sling system is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary tract infection, anticoagulant therapy, and/or infection in the operative field.Warnings: the implant procedure and the instrumentation associated with the surgical placement of the ajust® helical sling system carry an inherent risk of infection and bleeding, as do similar urological procedures.The use of surgical staples, clips, screws, or other non-suture attachment mechanisms not supplied with the ajust® helical sling system can damage the implant.After use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.Precautions: the usual precautions associated with urological procedures should be followed: an experienced and trained physician must determine ¿ based on a thorough preoperative assessment ¿ whether the patient and the underlying condition is suitable for the implant procedure.Additional consideration should be given to use of the implant in patients with a compromised immune system, any condition that would compromise healing, or any patient with a history of prior abdominal or pelvic surgeries.Consideration should also be given to the ability of the patient to tolerate the surgical procedure.Accepted surgical practice and precautions must be followed for the management of contaminated or infected wound sites, when the ajust® helical sling system is used.Postoperative bleeding may occur in some patients and must be controlled prior to patient release.The implant procedure requires diligent attention to anatomical structures and diligent care to avoid injury of large vessels, nerves, bladder, bowel, urethra and any viscera during introducer passage.Anatomical distortion can result from pelvic organ prolapse.If the patient requires cystocele repair, it should be performed prior to the implantation of the suburethral sling.Proper placement of the sling implant at the mid-urethra requires that it lie flat with minimal or no tension under the urethra.The ajust® helical sling system is intended as a single-use device.Do not resterilize any portion of the ajust® helical sling system.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Patients should be advised that pregnancy following a sling implant procedure may negatively affect the success of such implant procedure and incontinence may recur.The patient is advised to consult with the physicians in case of a planned pregnancy.The safety and effectiveness of the ajust® helical sling system implant procedure has not been established for the treatment of stress urinary incontinence in males or children under the age of 18.Cystoscopy should be considered at the physician¿s discretion.Check the integrity of the packaging before use.Do not use the implant or introducers if the packaging is opened or damaged.As for any implantable material, it is recommended to first open the package at the time of implantation.Upon opening the ajust® helical sling system tray, the components should be carefully transferred into the sterile field.The tray should not be inverted to remove components.Post operatively the patient should be advised to refrain from heavy lifting, exercise (e.G.Cycling, jogging) and/or intercourse until the physician determines it is suitable for the patient to return to normal activities.Adverse events: complications associated with the proper implantation of the ajust® helical sling system may include, but are not limited to: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with over correction/typically too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, vagina, rectum or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera or adjacent organs.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence.Implant procedure: the ajust® helical sling system may be implanted using local, regional, or general anesthesia.Operative preparation: position the patient in a dorsal lithotomy position with hips in flexion at approximately 90 degrees and the buttocks even with the edge of the table.Standard operative preparation of the surgical site should be completed.Insert a foley catheter and drain the bladder until empty.Identify the mid-urethra by first locating the external urethral meatus and then the bladder neck by identifying foley catheter balloon.Inject solution (e.G., 1% lidocaine with epinephrine) at the midline between the vaginal wall and urethra, hydrodissecting and creating an urethro-vaginal space.Additional hydrodissection can be performed by injecting solution laterally towards the cephalad aspect of the ischiopubic ramus in order to better identify the lateral sulci.Place allis clamps at the level of the mid-urethra on the anterior vaginal wall.Make a small (approximately 1.5 cm) incision in the anterior vaginal wall beginning approximately 1 cm under the urethral meatus.The depth of the incision should extend into the vaginal muscularis.Gently free the urethra from the anterior vaginal wall.Using scissors (e.G., metzenbaum scissors), dissect laterally in a 45 degree angle until the tip of the scissors makes contact with the medial-cephalad aspect of the ischiopubic ramus (approximately 1-2 cm).This procedure is repeated on the contralateral side.Ajust® implant placement using helical introducers operative guidelines: the ajust® helical sling system is packaged with the fixed anchor of the sling implant preloaded in the introducer intended for placing the fixed anchor into the patient¿s right side obturator muscle/membrane complex.Prior to insertion, ensure that the sling implant is extended in line with the introducer handle.This will aid in visualization of the blue midline indicator during insertion of the anchors (figure 2).Note: prior to introducer insertion, read the placement guidelines below when the anchors are properly deployed in the correct anatomical location, they provide secure fixation in the surrounding tissue.If an anchor is positioned incorrectly (e.G., if the midline indicator is greater than 1 cm away from the urethra), apply gentle traction to ¿test¿ securement.If the anchor can be loosened or removed with reasonable force and with minimal tissue disruption, reload the anchor in the introducer and repeat the insertion.If substantial resistance is encountered, it is recommended to section the sling laterally to preserve the surrounding tissue integrity.After sectioning, another sling procedure may be performed.Insert the introducer into the vaginal dissection laterally through one of the dissected planes toward the cephalad aspect of the ischiopubic ramus.Angle the introducer towards the superior-medial aspect of the obturator foramen.Allow the introducer to drift cephalad to position the anchor behind the ischiopubic ramus.Confirm that the anchor is behind the ramus and using only gentle thumb/finger pressure, push the fixed anchor into the tissue until it is slightly beyond the ramus.Note: maintaining a more horizontal plane of the introducer handle during the entire passage may aid in placement.A high angle could lead to the anchor tip hitting the body of the symphysis or inferior margin of the superior ramus.Rotate the handle (on its axis) driving the fixed anchor through the obturator internus muscle/membrane complex (typical rotation of the handle will be between 45 and 60 degrees, not to exceed 90 degrees).At least one distinctive pop may be heard, indicating perforation of the muscle/membrane.The midline indicator should be utilized to assess the depth of the fixed anchor placement.The midline indicator should be slightly past the mid-urethra (about 0.5 cm) in the direction of insertion.Release the fixed anchor by pushing the release lever forward in the introducer handle (refer to figure 3).Gently retract the introducer handle by reversing through the insertion path.After releasing the fixed anchor, apply gentle traction to the suburethral sling to confirm secure fixation in the tissue.Place the adjustable anchor into the other introducer and secure by retracting the release lever on the handle (refer to figure 4).A slight ¿click¿ should be felt or heard to confirm secure loading.Prior to the next insertion, ensure that the sling implant is not twisted.Slide the adjustable anchor along the mesh 2-3 times to confirm proper orientation of mesh through the anchor.Ensure that there are at least 4 cm of adjustable mesh between the suburethral sling and the adjustable anchor prior to insertion.(the ajust® helical sling system is packaged with the adjustable anchor approximately 4 cm from the suburethral sling.) insert the adjustable anchor in the contralateral dissection plane and orient the introducer towards the superior-medial aspect of the obturator foramen.Allow the introducer to drift cephalad to position the anchor behind the ischiopubic ramus.Confirm that the anchor is behind the ramus and using only gentle thumb/finger pressure, push the fixed anchor into the tissue until it is slightly beyond the ramus.Rotate the handle (on its axis) driving the adjustable anchor through the obturator internus muscle/membrane complex (typical rotation of the handle will be between 45 and 60 degrees, not to exceed 90 degrees).At least one distinctive pop may be heard, indicating perforation of the muscle/membrane in the superior-medial aspect of the obturator foramen.Release the adjustable anchor by pushing the release lever forward in the introducer handle.Gently retract the introducer by reversing through the insertion path.After releasing the adjustable anchor, apply gentle traction to the suburethral sling, followed by adjustment of the mesh in order to confirm secure fixation in the tissue.Gently pull on the adjusting tab to adjust the suburethral sling.To aid in adjustment, insert a finger vaginally to stabilize the adjustable anchor at the obturator internus muscle.The sling can also be loosened by using gentle counter-traction on the suburethral sling on the adjustable side of the sling implant.A thin, blunt instrument (such as a hemostat) between the urethra and the suburethral sling may be used as a spacer to aid in setting the appropriate tension.A cough or créde test can also be employed to achieve the appropriate tension.The midline indicator should be visible at the patient¿s midline, no more than 1 cm away from the urethra in either direction.Once proper tensioning is achieved, insert the flexible stylet into the adjusting tab opening and slide it up the adjustment mesh to push the sling lock into place at the adjustable anchor (refer to figure 5).When properly seated, the flexible stylet will bow, signifying that the sling lock is in the proper location and the sling implant has been secured.Note: once the sling is locked, additional tightening can be achieved using the adjusting tab.Once desired tension has been achieved, repeat the above step for securing the sling.Remove the flexible stylet after final securement of the sling implant.Insert metzenbaum scissors into the incision and trim the excess adjustment mesh lateral to the urethra at the level of the anterior sulcus.Close the vaginal incision using suture.Storage: store at ambient temperature.Do not use the device past the last day of the labeled month of the expiration date.Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity.Do not use the device if the integrity of the packaging appears compromised." (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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