MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

Catalog Number 486201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Asthma (1726); Erosion (1750); Bronchitis (1752); Cyst(s) (1800); Dehydration (1807); Diarrhea (1811); Fever (1858); Fistula (1862); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Unspecified Infection (1930); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Vomiting (2144); Urinary Frequency (2275); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Bowel Perforation (2668); Dysuria (2684); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The alleged event is most likely associated with possible procedural/surgical complications.The ifu currently addresses potential risks associated with surgically implantable materials which states the following: adverse reactions: potential adverse reactions are those typically associated with surgically implantable materials, including hematoma, seroma, mucosal or visceral erosion, infection, inflammation, sensitization, dyspareunia, scarification and contraction, fistula formation, extrusion and recurrence of vaginal wall prolapse.Perforations or lacerations of vessels, nerves, bladder, bowel, rectum, or any viscera may occur during needle passage.Precautions: caution: federal (usa) law restricts this device to sale by or on the order of a physician.The avaulta plus¿ biosynthetic support system should only be used by physicians who are trained in the surgical procedures and techniques required for pelvic floor reconstruction and the implantation of nonabsorbable meshes.Acceptable surgical practices should be followed for the management of infected or contaminated wounds.The avaulta plus¿ biosynthetic support system implantation procedures require diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, bowel, rectum, or other viscera during needle passage.The avaulta plus¿ biosynthetic support system is provided in a sterile blister tray within a sterile pouch.The sterile blister tray may be placed in the sterile field.The introducers provided with the anterior and posterior support systems are provided in a sterile blister tray.Transfer the introducer to the sterile field using aseptic techniques.Do not place the tray in the sterile field.Check the integrity of the packaging before use.Do not use the mesh or introducers if the packaging is opened or damaged.As for any implantable material, it is recommended to open the blister tray at the time of implantation.After use, any unused product and 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.(b)(4).No sample received.

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced extreme pain, vaginal erosion, extrusion and bleeding requiring mesh removal, infection, urinary problems, bowel problems, fistulae, recurrence, dyspareunia and vaginal scarring.Per additional information received via medical records on 5/14/2018, the patient has experienced mesh erosion, chronic pelvic pain, scar tissue, quite a bit of bleeding intraoperatively during posterior mesh removal, passing of stool from vagina, rectovaginal fistula, extensive adhesions from previous abdominal surgeries involving the small bowel loops and the abdominal wall in addition to the omentum and the abdominal wall, postoperative pneumoperitoneum (air within the peritoneal cavity), abdominal pain, per abdominal series mild prominence of the small bowel loops suggestive of ileus, intestinal obstruction, recurrent small bowel obstruction, intractable nausea, decreased ileostomy output, food bolus obstruction of the ileostomy, vaginal fistula, moderate amount of free fluid in the pelvis with intermediate layering density, postsurgical pain, fever, difficulty with urination, sepsis, urinary tract infection klebsiella , colovaginal fistula, dysuria, urinary frequency, urinary hesitation, nocturia, incontinence, enuresis, atherosclerotic vascular changes of the abdominal-pelvic vasculature, partially distended urinary bladder with mild urothelial enhancement, small urethral diverticulum, small focus of anterior rectal wall defect with extravasation of rectal contrast into the vaginal cavity, chronic diarrhea, weight loss, dr.(b)(6) suggested the patient see if her back problems were causing nerve issues with bladder, urinary retention, failed voiding trial, leakage, urinary urgency, drips all night, and wearing protective pads.She required surgical and non-surgical interventions such as mesh removal x2 and anterior and posterior repair ((b)(6) 2013), laparoscopic lysis of adhesions and loop ileostomy creation ((b)(6) 2013), placement of picc line for postoperative pneumoperitoneum ((b)(6) 2013), closure of loop ileostomy ((b)(6) 2014), cystoscopy with coaptite injection ((b)(6) 2014), colonoscopy, flexible sigmoidoscopy with biopsy , estrogen cream, myrbetriq, augmentin, probiotic, questran, foley catheter placement and removal for urinary retention, and voiding trials.Per the pfs she also alleged sharp protrusions in vagina that felt like needles in vagina, could not have sex with spouse as he would feel the sharp protrusions, removal of sharp protrusion in 2012 from vagina, bowel perforation, rectocele, and recurring stabbing pain in vagina.Per additional information received via medical records on 30mar2022, the patient has experienced urinary retention, overactive bladder, incontinence, infection, exacerbation of her chronic lung disease, partial gastric obstruction intractable nausea, vomiting, dehydration, steroid dependent asthma, hypertension, vaginal pain, pelvic pain, mesh erosions, constipation, bladder spasms, blister, tiny hole between the vagina and the rectum, vomiting, epigastric pain, granulation tissue, bowel movement, rectovaginal fistula, diarrhea, urethral diverticulum, irritable bowel, sebaceous cyst on left labia, obesity, diabetes, prolapse with a stage ii apical, stage i anterior, and stage ii posterior prolapse, dyspareunia, hematuria, sharp protrusions in vagina, vaginal irritation, stool coming out of vagina, urgency, bronchitis, bowel obstruction, bowel perforation, hypotension, rectocele, fever, and required additional surgical and non-surgical interventions.

• Brand Name: AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Type of Device: AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 14159860
• MDR Text Key: 289611460
• Report Number: 1018233-2022-90014
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2008
• Device Catalogue Number: 486201
• Device Lot Number: CVRH0024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AVAULTA PLUS® BIO ANTERIOR
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 96 KG