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The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿¿ note: when using the avaulta plus¿ biosynthetic support system, the tissue layer of the graft may be oriented to face the vaginal mucosal tissue or the visceral side at the discretion of the physician.To help facilitate the desired orientation, the colored markers on the arms should be positioned on the patient¿s right side for the tissue layer to be positioned on the vaginal mucosal side.Conversely, the arm markers should be oriented on the patient¿s left side for the tissue layer to face the visceral side.¿ proximal end with apical flap positioned at vaginal apex ¿ proximal arms (long arms with pointed ends) passed through ischiorectal fossa ¿ distal end positioned at perineal body ¿ distal arms (short arms with rounded ends) passed through ischiorectal fossa 1.Place the patient in stirrups in the lithotomy position and prepare for surgery using standard operative procedures.2.Make an incision in the posterior vaginal wall through the vaginal mucosa and into the fascial plane between the mucosa and the rectum.Use blunt and sharp dissection to dissect the vaginal mucosa away from the rectum laterally to the pelvic sidewalls and proximally to the ischial spine on both sides.Ensure a thick dissection is created, leaving as much endopelvic fascia on the mucosa as possible.3.Make two small pararectal incisions (>1 cm) approximately 3 cm lateral and 3 cm posterior to the anus.4.Locate the introducer needle and ensure that the snare is fully retracted into the needle tip prior to inserting the needle.Orient the introducer needle with the handle positioned vertically and the needle tip horizontal and parallel to the vaginal floor.Insert the needle tip into one of the pararectal incisions, aiming the needle tip towards the ischial spine.Pass the introducer through the ischiorectal fossa passing lateral to the posterior wall of the rectum until the needle tip nears the ischial spine, so that the proximal arms of the graft can be placed at or just cephalad to the level of the ischial spine.Move the handle downwards to direct the needle tip upwards approximately 1 cm proximal to the ischial spine and out through the posterior vaginal wall incision, exposing at least 1-2 cm of the needle tip.At the physician¿s discretion, the proximal arms may be secured through the sacrospinous ligament using a similar motion.Exercise care not to tear the pelvic tissue during passage.Insert a right-angle retractor into the vagina along the anterior wall and extend the introducer snare using the thumb slider on the introducer handle.The introducer tip should be stabilized with two fingers during initial deployment of the snare.If necessary, guide the end of the snare to the introitus with a finger.Extend the thumb slider until the snare loop has fully exteriorized itself.Note: it is recommended that a rectal probe be used to divert the rectum away during the needle passage.5.Pass the proximal mesh arm (pointed end) up to the fold (about 5 cm) through the eyelet in the snare.Retract the snare using the thumb slider until it reaches the stop position.Take care to prevent the surrounding tissue from getting caught in the snare during retraction.Retract the introducer needle to draw the mesh arm out through the pararectal skin incision.Ensure the mesh arm is not twisted during or after placement.Repeat steps 4 and 5 on the contralateral side.Note: if substantial resistance is felt during retraction of the introducer needle, ensure that no tissue has been caught in the needle during the snare retraction.Should this occur, re-extend the snare using the thumb slider mechanism, remove the trapped tissue, and re-retract the snare.6.Apply traction to draw the proximal arms of the graft into the desired position such that the proximal end of the central graft is positioned at the vaginal apex.Avoid placing excessive tension on the graft.7.Approximate the total vaginal length over which the graft will provide support.If necessary, use scissors to remove as much of the distal portion of the collagen sheet as is necessary so that the collagen terminates inside the vaginal introitus.Make a vertical cut along the blue center line of the polypropylene mesh to just inside the vaginal introitus to allow the graft to lie flat over the rectum once the distal arms are placed.8.Locate the introducer needle and ensure that the snare is fully retracted into the needle tip prior to inserting the needle.Insert the tip of the introducer needle into the same pararectal incision created in step 3 and orient the needle tip towards the vaginal introitus.Exercise care to stay lateral to the anal sphincter and rectum during passage.Use a vaginal finger to guide the needle tip through the posterior vaginal wall incision at the perineal body and at the most lateral portion of the dissection (the junction of the transverse perineal and bulbocavernosus muscles), exposing at least 1-2 cm of the needle tip.Extend the introducer snare using the thumb slider on the introducer handle until the snare loop has fully exteriorized itself at the vaginal introitus.9.Pass the distal mesh arm (rounded end) 3-4 cm through the eyelet in the needle tip.Retract the snare using the thumb slider until it reaches the stop position.Retract the introducer needle to draw the mesh arm out through the pararectal skin incision.Ensure the mesh arm is not twisted during or after placement.Repeat steps 8 and 9 on the contralateral side.10.Apply traction to draw the distal arms of the graft into the desired position such that the distal end of the central graft is positioned next to the perineal body.The colored midline marker may be used to facilitate desired placement of the graft.Ensure the central mesh lays over the rectum without excessive tension.A digital rectal exam should be performed to confirm integrity of the rectum after the mesh is positioned.11.The mesh should be sufficiently anchored to stabilize it during tissue ingrowth.Additional sutures may be used to secure the mesh tension-free.Anchoring points should be positioned at least 1 cm from the edge of the mesh.Extra care should be used when positioning the avaulta plus¿ biosynthetic support system implant to prevent tearing of the acellular collagen sheet.After desired positioning is complete, at the physician¿s discretion, the entire graft and incision line may be irrigated with an appropriate antibiotic solution.Trimming of the vaginal mucosa should be limited to only mucosal edges damaged by instruments.Caution: excessive tension should be avoided on the mesh and suture attachment points to account for wound shrinkage during the healing process.12.Close the posterior vaginal wall incision using a running stitch.It is advised to use a monofilament suture for closure, though it is not advised to use an interrupted or locking stitch as this may cause excessive hemostasis, resulting in delayed closure.Trim all ends of the mesh arms below the level of the skin and close skin incisions.Sterilization technique avaulta plus¿ biosynthetic support system is a single-use device.The implant and introducers are sterilized by ethylene oxide.Do not resterilize.Storage recommended storage conditions: between 2°- 40°c (36°-105°f) in a dry area.Patent pending.Copyright ©2010 c.R.Bard, inc.All rights reserved." correction:concomitant medical products and device evaluated by mfr.Patient code: (b)(4).
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