AVAULTA POSTERTOR BIOSYNTHETIC SUPPORT SYSTEM
Report
- Report Number
- 1018233-2012-01494
- Event Type
- Other
- Date Received
- November 1, 2016
- Report Date
- May 8, 2013
- Manufacturer
- SOFRAD]M PRODUCTION
- Product Code
- OTP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
H11: SECTION A THROUGH F - 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.
PER ADDITIONAL INFORMATION THE HAS EXPERIENCED BLADDER PERFORATION WITH RETROPUBIC URETHRAL SUSPENSION NEEDLE (INTRAOPERATIVE), RECURRENT URINARY TRACT INFECTION (UTI)-E COLI), PERSISTENT STRESS INCONTINENCE (LEAKS WITH COUGHING), PROBABLE INTRINSIC URETHRAL SPHINCTER DEFICIENCY, DYSURIA FROM SLING, ABNORMAL VAGINAL DISCHARGE, MILD CYSTOCELE, URINARY RETENTION REQUIRING STRAIGHT CATHETERIZATION, RIGHT SUPRAPUBIC TENDERNESS, PROBABLY RIGHT RESIDUAL OVARY SYNDROME (RIGHT LOWER QUADRANT PAIN), URINARY FREQUENCY, URINARY URGENCY, CYSTITIS, APEX TENDERNESS, LEFT OVARY ENLARGED, LEFT LOWER QUADRANT PAIN, HEMATURIA, NOCTURIA, SCAR TISSUE BAND AT VAGINAL APEX PRESUMABLY SECONDARY TO PREVIOUS PELVIC RECONSTRUCTIVE SURGERY, OMENTAL ADHESIONS TO THE OMENTAL ABDOMINAL WALL AND PELVIC SIDEWALL, AND LEFT TUBE AND OVARY, FEVER 101, RIGHT FLANK PAIN, NAUSEA, AND VOMITING (PYELONEPHRITIS), ABDOMINAL DISTENTION WITH SUPRAPUBIC TENDERNESS, DILATATION OF LEFT URETER WITHOUT EVIDENCE OF STONE, MILD HYDRONEPHROSIS OF LEFT KIDNEY WITH MINIMAL PROMINENCE OF THE COLLECTING SYSTEM RIGHT KIDNEY BILATERAL FLANK PAIN AND BLADDER PAIN, YELLOWISH DISCHARGE WITH ODOR, PALPABLE SLING MID POSTERIOR VAGINAL WALL AS WELL AS UNDER URETHRA, MONILIAL, WHITE, RED, AND BROWN VAGINAL DISCHARGE AND ODOR, BACTERIAL VAGINOSIS, OTHER BLEEDING AFTER INTERCOURSE, FOREIGN BODY IN GENITOURINARY TRACT, SERIAL# OTHER # ANTERIOR/POSTERIOR WALL MESH IS INDUCING PAIN WITH FUNCTIONAL URINARY OBSTRUCTION, TWO BOWEL MOVEMENTS PER WEEK, TIGHT MIDURETHRAL WITH SOME OVERLAP OF ANTERIOR GRAFT OVER THE BLADDER NECK AND URETHRA, RECTAL PAIN AND BLEEDING, SMALL 3 MM EXCORIATION ON THE RIGHT ANTERIOR VAGINAL WALL, SINCE (B)(6) 2008 UNABLE TO EMPTY BLADDER AND PERFORMING INTERMITTENT STRAIGHT CATHETER ON A DAILY BASIS, STRAINING URGE SYMPTOMS, SLIGHT POSTERIOR RIDGE FROM THE PREVIOUS GRAFT PLACEMENT, ABSENT BULBOCAVERNOSUS AND CLITORAL-ANAL REFLEXES, BLADDER SLING IS PLACED AT BLADDER NECK-VERY CLOSE TO KINKING, ANTERIOR WALL MESH WHICH IS WRINKLED AND FRAGMENTED AND EXTENDS UP AROUND THE URETHRA ON THE LEFT, POSTERIOR WALL MESH IS ALSO VERY WRINKLED AND TENDER, POSTERIOR MESH LOOKING AS THOUGH EXTENDS AROUND THE RECTUM ON THE LEFT AND ACROSS THE POSTERIOR PUBORECTALIS ON THE RIGHT, MARKED PELVIC FLOOR DYSFUNCTION AND HIGH TONE, POSTOPERATIVE VOIDING OBSTRUCTION AFTER SLING PROCEDURE, URGE INCONTINENCE, ANTERIOR VAGINAL MESH EROSION, LARGE ENTEROCELE, SLING MIGRATION LYING TIGHT UP AGAINST THE BLADDER NECK CAUSING BLADDER NECK ELEVATION, "SEVERAL" AREAS OF MESH EROSION WITH SEROSANGUINEOUS DRAINAGE IN "VARIOUS" AREAS, TRIGONE SCARRING AND MEDIAL RETRACTION, "SEVERAL" EPISODES OF HEAVY VAGINAL BLEEDING, MESH EXTENDED UPWARDS TOWARDS ENTEROCELE, "STOMACH PAIN SINCE SURGERY" (PCP FEELS MIGHT BE RELATED TO LONGTERM ASA USE, DIFFICULTY WITH DEFECATION (HAS TO APPLY VAGINAL AND PERINEAL PRESSURE TO HAVE A BOWEL MOVEMENT), RIDGE BETWEEN DISTAL ASPECT OF POSTERIOR GRAFT AND PERINEAL BODY ((B)(6) 2010), TIGHT MIDURETHRAL SLING WITH SOME OVERLAP OF ANTERIOR GRAFT OVER THE BLADDER NECK AND URETHRA (4D ULTRASOUND), FATIGUE, SIGNIFICANT PAIN WITH DEFECATION, BAND OF POSTERIOR MESH PALPABLE 3 CM ABOVE DISTAL RECTOCELE ((B)(6) 2010), TIGHT ANTERIOR VAGINAL BAND WITH POSSIBLE MESH EROSION ON THE RIGHT ANTERIOR SIDE VERY TENDER ON PALPATION ((B)(6) 2010), PAINFUL THICKENED RECTAL MUSCULARIS/RECTOVAGINAL SEPTUM ADJACENT TO SUPERIOR END OF POSTERIOR MESH AT INTACT MID VAGINA, "POSTERIOR MESH WRINKLED AND TENDER ON THE RIGHT AND WADDED INTO THE PERINEAL BODY," VAGINAL YELLOW PURULENT DISCHARGE WITH STOOL MIXED IN ((B)(6) 2010), HAVING DIFFICULTY DOING ANY ACTIVITY DUE TO PAIN AND PULLING SENSATION, "CONSISTENT WITH MESH THAT HAS AVULSED PERINEAL BODY AND RETRACTED SEVERAL CENTIMETERS ABOVE PERINEAL BODY AND IS FOLDED AND TENDER," POSTERIOR WALL VERY INDURATED IN AREA OF FOLDED MESH, VAGINAL PAIN, BLACK AND GREEN VAGINAL DISCHARGE, PERSISTENT FEVERS, HORIZONTAL THICK RIDGE THAT EXTENDS FROM THE VAGINAL CUFF ALL THE WAY TO THE RECTAL MUCOSA, TISSUE TOO ADHERENT TO UNDERLYING RECTAL MUCOSA THAT IS WAS UNABLE TO BE REMOVED VAGINALLY, PELVIC PRESSURE, VAGINAL MESH EROSION INTO RECTUM, RECTOVAGINAL FISTULA, COLON POLYPS, WHITE STUFF FLOATING IN TOILET, RECTAL ABSCESS/INFECTION, "MESH BUILT UP ON RIGHT SIDE INSIDE AND OUTSIDE OF RECTUM CAUSING PAIN REQUIRING NARCOTICS" ((B)(6) 2011), SMALL MESH EROSION POSTERIOR VAGINAL WALL, UNABLE TO TOLERATE SPECULUM EXAM SECONDARY TO PAIN, PALPABLE DEFECT IN RIGHT FORNIX, TENDERNESS WITH PALPATION OF ANTERIOR RECTAL WALL, THICKENING APPROXIMATELY 2.5 CM FROM ANUS AND TENDER, "LOSING TISSUE EVERY TIME SHE GOES TO THE BATHROOM," INDURATED AREA ON THE RIGHT BUTTOCK ELICITS PAIN VAGINALLY WHEN EXAMINED (POSSIBLE GLUTEAL ABSCESS WITH QUESTIONABLE TRACKING IN THE PERIRECTAL SPACE), MUCOUS RECTAL DRAINAGE, VAGINA IS CONTRACTED AND TIGHT, RIGHT INFRA-LEVATOR, TRANS-SPHINCTERIC RECTO/ANAL FISTULA, ISCHIORECTAL FOSSA ABSCESS, PENROSE DRAIN FELL OUT, FEVER 102 ((B)(6) 2011), VAGINAL BLEEDING 4-5 PADS PER DAY, URINARY INCONTINENCE, VOIDING DYSFUNCTION, BLOODY VAGINAL DISCHARGE, AND PAIN LOWER ABDOMEN ((B)(6) 2011); HAD A BOWEL MOVEMENT, FELT A POP, FOLLOWED BY HEAVY VAGINAL BLEEDING ((B)(6) 2011); SMALL OPENING IN THE BUTTOCK ON THE RIGHT APPROXIMATELY 1 CM IN LENGTH AREA OF FISTULA REPAIR, LARGE BLOOD CLOTS FROM THE VAGINA (VAGINAL HEMORRHAGE), ANEMIA (HGB 7.3), BLOOD TRANSFUSIONS X 4 (PACKED RED BLOOD CELLS AND PLASMA), TORN VAGINAL MUCOSA FROM THE INTROITUS TO BELOW THE VAGINAL APEX, GRANULATION TISSUE OVER EDGES OF VAGINAL MUCOSA, GASTROPATHY, CONSTIPATION, A SMALL PELVIC FLUID COLLECTION 6.9 CM AND THERE WAS CONCERN OVER HEMATOMA VERSUS SEROMA VERSUS POSSIBLE ABSCESS, INDURATION LEFT POSTERIOR VAGINAL WALL ((B)(6) 2011), "DISCOMFORT DUE TO MESH RADIATING TO BOTH LEGS," DRAINAGE VAGINAL OR VIA SKIN AT BUTTOCK SIMILAR TO WHEN HAD ABSCESS IN BUTTOCK ASSOCIATED WITH MESH, SQUAMOUS MUCOSA IN INFLAMMATION AND FOREIGN BODY GIANT CELL REACTION TO MESH MATERIAL, POSSIBLE COMPLICATED BARTHOLIN CYST, AND CAN ONLY EMPTY BLADDER HALFWAY WITH SITTING. PER THE PFS, THE PATIENT ALSO EXPERIENCED LOWER ABDOMINAL INFLAMMATION, UNSPECIFIED ABNORMAL BOWEL MOVEMENTS, SUFFERED PSYCHOLOGICALLY AND EMOTIONALLY, UNSPECIFIED BOWEL LEAKAGE, UNSPECIFIED INFLAMMATION, RANGE OF ACTIVITY DECREASED SIGNIFICANTLY DUE TO CHRONIC PAIN, UNABLE TO TAKE CARE OF HOUSEHOLD RESPONSIBILITIES, NO LONGER ENJOYS GOING OUT IN PUBLIC, "HYPERTENSION OR LOW BLOOD PRESSURE," PERITONITIS/SEPSIS (PRE OR POST IMPLANT NOT INDICATED), AND UNSPECIFIED VAGINAL INFECTIONS. THE PATIENT UNDERWENT AN UNKNOWN BOWEL SURGERY, BLADDER TACK, EXAMS UNDER ANESTHESIA X 4, RETROPUBIC MIDURETHRAL SLING PROCEDURE, MULTIPLE CYSTOSCOPIES, DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPIC ADHESIOLYSIS, LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY, DIVISION OF VAGINAL SCAR TISSUE BAND, SLING EXCISION/REVISION, ANTERIOR WALL MESH REMOVAL, VAGINAL ENTEROCELE REPAIR, ATTEMPTED POSTERIOR VAGINAL WALL MESH REVISION, WIDE-EXCISION OF ISCHIORECTAL ABSCESS WITH PENROSE DRAIN PLACEMENT, PROCTOSCOPY, DIFFICULT EXCISION OF POSTERIOR VAGINAL MESH, VAGINAL MUCOSA DEBRIDEMENT, AND REPAIR OF VAGINAL LACERATION/BREAKDOWN.
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED STRESS URINARY INCONTINENCE, ABDOMINAL PAIN, DYSURIA, INFECTION, INFLAMMATION, MESH EROSION, MESH EXTRUSION, DYSPAREUNIA, PELVIC PAIN, RECTAL BLEEDING, SCARRING, URGENCY OF URINATION (URINARY URGENCY), URINARY RETENTION, URINE LEAKAGE, VAGINAL BLEEDING, BLOOD LOSS, BLADDER PERFORATION WITH RETROPUBIC URETHRAL SUSPENSION NEEDLE, DEFECT (PERFORATION OF ORGAN), CYSTOCELE, ENTEROCELE (PROLAPSE), OPENED ENTEROCELE, LEAKAGE OF URINE FROM THE ANTERIOR VAGINAL WALL, CHRONIC PELVIC PAIN DUE TO SLING, MESH DISLODGEMENT, RECTAL PAIN, INCONTINENCE, TENDERNESS, WALL THICKENING, PROTRUDING MESH, URINARY TRACT INFECTION, DEFECTIVE BLADDER SLING, RECTAL MESH TORE THROUGH MUSCLES, ISCHIO-PERIRECTAL PERIRECTAL ABSCESS, TRACKING (ABSCESS), FEELING OF MESH BUILD UP (FOREIGN BODY SENSATION), BEDBOUND FROM PAIN, STOOL-LIKE SUBSTANCE COMING FROM VAGINA, URINARY INCONTINENCE, VOIDING DYSFUNCTION, POST-VOID DRIBBLING, NOCTURIA, HEMATURIA, SENSATION OF BULGING, PROTRUSION FROM VAGINAL, RECTAL AREA, BULGE, SOMETHING FALLING OUT THAT CAN SEE, FEEL IN VAGINAL AREA, DEFECATORY HARD STRAINING, RECTOVAGINAL, PERINEAL FISTULA TRACK (FISTULA), PAIN, COMPLICATION OF VAGINAL MESH, CONTRACTURE, CHRONIC VAGINAL DISCHARGE, DRAINAGE FROM RIGHT BUTTOCK, INDURATED AREA, PAIN, EXPOSED MESH, SCARRED IN POSTERIOR MESH, MESH IN POSTERIOR VAGINAL WALL, BANDING, CRAMPING, VAGINAL BLEEDING WHILE HAVING BOWEL MOVEMENT, BLOODY STOOLS, DIZZINESS, LIGHTHEADEDNESS, VAGINAL HEMORRHAGE (HEMORRHAGE), VAGINAL LACERATION (LACERATION), BREAKDOWN OF PREVIOUS REPAIR, TORN VAGINAL MUCOSA (VAGINAL MUCOSA DAMAGE), SUTURES PRESENT, BROKEN, GRANULATION TISSUE, POSTERIOR VAGINAL DEFECT, ANTIBIOTIC REACTION, PROBLEMS WITH DEFECATION, CANNOT EMPTY COMPLETELY, VAGINAL AND PERINEAL PRESSURE TO EMPTY, THICK RIDGE, TISSUE, POSTOPERATIVE VOIDING OBSTRUCTION, URINARY TRACT OBSTRUCTION (OBSTRUCTION), UNABLE TO VOID, TIGHT SLING, OVERLAP OF GRAFT, BOWEL, RECTAL DYSFUNCTION, FOREIGN BODY IN GENITOURINARY TRACT (FOREIGN BODY IN PATIENT), URGE INCONTINENCE, TENDER SLING, WRINKLED, FRAGMENTED MESH, PELVIC FLOOR DYSFUNCTION, HIGH TONE, MESH FOLDING, INDURATED MESH, DENSELY ADHERENT (ADHESION), VAGINAL WALL FIRMNESS, MIGRATED SLING, SCARRED, RETRACTED TRIGONE, BUNCHED UP MESH, OPEN VAGINAL MUCOSA, PALPABLE MESH, SLING UNDER TENSION, SEXUAL DYSFUNCTION, DISCHARGE, HEADACHE, FATIGUE, TIREDNESS, MALAISE, BAND OF FIBROSIS, DISCOMFORT, PALENESS, RUPTURED CYST (CYST), LOSING TISSUE EVERY TIME GOES TO BATHROOM, PAIN WHEN SITTING, URINARY FREQUENCY, URINARY INCONTINENCE, CONTRACTED, TIGHT VAGINA, MUCOUS RECTAL DRAINAGE, BACK PAIN, PENROSE DRAIN FELL OUT, FEVER, INFLAMMATION, FOREIGN BODY GIANT CELL REACTION (FOREIGN BODY REACTION), WEAKNESS, NIGHT SWEATS, TINGLING, NUMBNESS, NAUSEA, HEARTBURN, VOMITING, DIARRHEA, SLEEP DISTURBANCES, HOT FLASHES, TENDER, FULLNESS RIGHT LOWER QUADRANT, EMOTIONAL CHANGES, DEPRESSION, URINE, VAGINAL ODOR, WEIGHT LOSS, FLANK PAIN, KIDNEY, BLADDER PAIN, SWOLLEN ENLARGED KIDNEYS, MONILIA (FUNGAL INFECTION), BACTERIAL VAGINOSIS (BACTERIAL INFECTION), BURNING, PELVIC PRESSURE, VAGINAL IRRITATION, PAIN, ITCHY, VOIDS SMALL AMOUNTS, ATROPHIC VAGINITIS (INFLAMMATION), AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.
COMPLAINT #(B)(4). PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN, SEVERE PAIN DURING INTERCOURSE, URINARY INCONTINENCE, RETENTION AND LEAKAGE ALONG WITH URINARY AND VAGINAL INFECTIONS, LOWER ABDOMINAL INFLAMMATION, VAGINAL BLEEDING, VAGINAL DISCHARGE, ABNORMAL BOWEL MOVEMENTS, AND BOWEL LEAKAGE. ASSOCIATED MDRS: 1018233-2012-01495, 1018233-2012-01496, AND 1018233-2012-01493.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722776 | AVAULTA POSTERTOR BIOSYNTHETIC SUPPORT SYSTEM | NO MATCH | OTP | SOFRAD]M PRODUCTION | NA | ZGK00766 | |
| 722777 | AVAULTA POSTERTOR BIOSYNTHETIC SUPPORT SYSTEM | NO MATCH | OTP | SOFRAD]M PRODUCTION | NA | ZGK00766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention | ALIGN URETHRAL SUPPORT SYSTEM | AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM |