MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA SOLO¿ SYNTHETIC SUPPORT SYSTEM - ANTERIOR, STERILE; AVAULTA SOLO ANTERIOR

Catalog Number 486100

Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Abnormal Vaginal Discharge (2123)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that a patient had several mesh implants which resulted in mesh extrusion requiring surgery to remove.The patient experienced bleeding (vaginal), discharge (vaginal), urinary leaking, and additional surgery.The patient also had mesh erode into her rectum.She is on estrogen to keep the vaginal walls thick.

Event Description

It was reported that a patient had several mesh implants which resulted in mesh extrusion requiring surgery to remove.The patient experienced bleeding (vaginal), discharge (vaginal), urinary leaking, and additional surgery.The patient also had mesh erode into her rectum.She is on estrogen to keep the vaginal walls thick.

Manufacturer Narrative

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: the avaulta solo¿ support system does not require a particular orientation with respect to mucosal or visceral sidedness.¿ proximal end with apical flap positioned at vaginal apex ¿ proximal arms (long arms with pointed ends) passed through inferior medial aspect of obturator membrane ¿ distal end positioned at bladder neck ¿ distal arms (short arms with rounded ends) passed through superior medial aspect of obturator membrane 1.Place the patient in stirrups in the lithotomy position and prepare for surgery using standard operative procedures.2.Make a midline incision in the anterior vaginal wall starting 1 cm below the urethral meatus and extending to the vaginal cuff.Dissect the vaginal mucosa away from the bladder laterally to the obturator internus at the level of the bladder neck and proximally to the ischial spine on both sides.3.Identify the obturator fossa by grasping the adductor longus at its insertion to the pubic tubercle.Using the thumb to palpate under the adductor longus insertion, the superior medial aspect of the obturator fossa is identified.Palpate and draw the medial border of the obturator fossa to its inferior medial border.Make a vertical 1.5 cm incision approximately 1 cm below the superior medial border of the obturator fossa and lateral to the bladder neck for the distal arm of the mesh.Make a second vertical 1.5 cm incision at the inferior medial border of the obturator fossa and approximately lateral to the vaginal cuff.Repeat on the contralateral side.4.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 inferior medial groin incision to puncture through the obturator membrane.Orient the introducer in a horizontal plane, and direct the needle tip towards the ischial spine or top of the vaginal cuff.Identify the tip of the introducer before puncturing through the obturator internus muscle.With a gentle rotation of the introducer push through the obturator muscle and use the vaginal finger to guide the needle tip through the fascial wall to exit proximally at the vaginal apex, exposing at least 1-2 cm of the needle tip.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.5.Pass the proximal arm (pointed end) of the mesh 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 inferior groin 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." patient code: 2564.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: AVAULTA SOLO¿ SYNTHETIC SUPPORT SYSTEM - ANTERIOR, STERILE
• Type of Device: AVAULTA SOLO ANTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8579428
• MDR Text Key: 144095821
• Report Number: 1018233-2019-02325
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168024
• UDI-Public: (01)00801741168024
• Combination Product (y/n): N
• PMA/PMN Number: K083839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2010
• Device Catalogue Number: 486100
• Device Lot Number: HUSI1687
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention