| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AVAULTA SYNTHITEC SUPPORT SYSTEM | AVAULTA MESH | BARD SHANNON LIMITED -3005636544 | OTP | UNKNOWN | UNK | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-11-25 | 0 | 1. R |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. 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.
Patient 1
IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THE DEVICE IN 2007, THE PATIENT HAS ALLEGEDLY BEEN DIAGNOSED IN (B)(6) 2014 WITH A 0.5CM CENTRAL VAGINAL EROSION AND A PALPABLE RIGHT POSTERIOR ARM WITH NO EROSION, BUT WITH TENDERNESS AT THE SITE. EXCISION OF A PORTION OF THE MESH OCCURRED IN (B)(6) 2014.
Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "PRECAUTIONS BASED ON PHYSICIAN EXPERIENCE AND TRAINING, A THOROUGH ASSESSMENT OF EACH PATIENT SHOULD BE MADE TO DETERMINE THEIR SUITABILITY 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 INFECTED OR CONTAMINATED WOUNDS. POSTOPERATIVE BLEEDING MAY OCCUR IN SOME PATIENTS AND MUST BE CONTROLLED PRIOR TO PATIENT RELEASE. THE AVAULTA PLUS? BIOSYNTHETIC SUPPORT SYSTEM IMPLANTATION PROCEDURES REQUIRE DILIGENT ATTENTION TO ANATOMICAL STRUCTURES AND CARE TO AVOID PUNCTURE OF LARGE VESSELS, NERVES, BLADDER, BOWEL, URETHRA, RECTUM, OR ANY VISCERA DURING INTRODUCER 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. THE AVAULTA PLUS? BIOSYNTHETIC SUPPORT SYSTEM IS INTENDED AS A SINGLE-USE DEVICE. DO NOT RE-STERILIZE ANY PORTION OF THE AVAULTA PLUS? BIOSYNTHETIC SUPPORT 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. 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 REACTIONS COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE AVAULTA PLUS? BIOSYNTHETIC SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, 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 AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, REJECTION OF BIOLOGIC MATERIALS, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF VAGINAL WALL PROLAPSE. URINARY INCONTINENCE (STRESS AND URGE). IMPLANT PROCEDURES PREPARATION OF AVAULTA PLUS? BIOSYNTHETIC MESH FOR IMPLANTATION: AT THE TIME OF IMPLANTATION, AVAULTA PLUS? BIOSYNTHETIC SUPPORT SYSTEM MESH MUST BE HYDRATED. TO HYDRATE, PLACE THE AVAULTA PLUS? BIOSYNTHETIC SUPPORT SYSTEM MESH INTO THE BLISTER TRAY OR OTHER STERILE DISH AND COMPLETELY IMMERSE IN A STERILE PHYSIOLOGICAL SOLUTION FOR AT LEAST 3 MINUTES. AVAULTA PLUS? BIOSYNTHETIC SUPPORT SYSTEM MESH IS MORE EASILY TRIMMED PRIOR TO HYDRATION, BUT MAY BE TRIMMED AFTER HYDRATION IF DESIRED, TO APPROXIMATE THE TOTAL VAGINAL LENGTH OVER WHICH THE GRAFT WILL PROVIDE SUPPORT. IF NECESSARY, THE PROXIMAL PORTION OF THE GRAFT (APICAL EXTENSION) MAY BE REMOVED. CAUTION: THE MESH SHOULD NOT BE TRIMMED TO A WIDTH LESS THAN 1 CM IN ORDER TO MAINTAIN SUFFICIENT STRENGTH AND PREVENT UNRAVELING. IMPLANTATION TECHNIQUE FOR THE AVAULTA PLUS? BIOSYNTHETIC ANTERIOR SUPPORT SYSTEM: 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 ...