MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD DEBAKEY FABRIC; POLYESTER VASCULAR GRAFT

Catalog Number 007831

Device Problem Material Erosion (1214)

Patient Problem Abnormal Vaginal Discharge (2123)

Event Date 11/17/2006

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number is unknown.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Image/photo review: no medical images have been made available to the manufacturer: medical records review: medical records were provided, a review was performed.Based on the medical records received: patient had a surgical procedure to include a total abdominal hysterectomy, paravaginal repair, sacrocolpopexy, pubovaginal sling, and a posterior repair graft without incident.Approximately three years and nine months post vaginal mesh implant; surgical procedure was performed to remove the vaginal mesh (other manufacturer) located in the upper part of the vaginal cuff.Approximately four years and 10 months post vagina surgical mesh implant, a procedure performed under general anesthesia for a pelvic abscess with vaginal drainage.A large granuloma was identified and removed without incident.Beneath the granuloma was an elastic knit fabric that was removed without incident.The physician stated it was difficult to tell if any of the elastic knit fabric was left behind.Approximately five years post vaginal mesh implant; an examination performed under general anesthesia for possible erosion of granulation tissue was performed.The surgeon reported that a tremendous amount of granulation tissue bled freely upon touching, the granulation tissue was bovied to control the bleeding.No surgical mesh or sutures were identified during the examination.Four months later another examination performed under general anesthesia for pelvic abscess was performed.Upon careful inspection of the vagina there is no evidence of an elastic knit fabric identified.The surgeon stated the patient symptoms probably are attributed to ongoing granulation tissue issues.No foreign body was identified.Conclusion: the investigation is inconclusive for the alleged material erosion.The medical records do not provide evidence that the debakey fabric in question was clearly eroding within the patient after implantation.The relationship of the symptoms of the patient to debakey fabric is unclear from provided information.Per the provided medical records, the possible erosion of granulation tissue and continued issues with granulated tissue after removal of implants could be the potential cause of the symptoms associated with reported event.However, the definitive root cause and the products role in the alleged symptoms is unknown.Labeling review: the current ifu (instructions for use) states: warnings: as with all woven fabric constructions, care must be taken when trimming the fabric to minimize the potential for fraying at cut edges.Cautery is highly recommended for heat sealing on all woven patch edges.If the edges of the fabric are not heat sealed, then sutures must be at least 2mm from the cut edge.Adverse reactions: adverse reactions that may occur with the use of these products or with any cardiovascular implant procedure include perioperative hemorrhage, implant bleeding, tissue erosion, anastomotic aneurysms, and infection.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.

Event Description

It was reported that a surgery was performed to include; total abdominal hysterectomy; a vaginal mesh (other manufacturer) for the vagina cuff, elastic knit fabric for paravaginal repair, and a urethral synthetic sling (other manufacturer) were successfully implanted.Approximately three years and nine months post vaginal mesh implant; a procedure under general anesthesia for pelvic mass and vaginal mesh erosion was performed.The operative notes stated that most of the vaginal mesh (other manufacturer) was removed successfully.Approximately four years and 10 months post elastic knit fabric implant, under general anesthesia the pelvic abscess was drained, a large granuloma was removed, and the elastic knit fabric was removed.Granulation tissue was bovied for bleeding.Approximately five years post total abdominal hysterectomy two additional surgical procedures were performed under general anesthesia for possible erosion of granulation tissue.The surgeon identified a tremendous amount of granulation tissue that bled freely upon touch; the granulation tissue was bovied to control the bleeding.Under careful examination, no vaginal mesh or elastic knit fabric was identified.The patient was hemodynamically stable at the conclusion of the procedure.The operative report concluded that the patient's ongoing symptoms may be based on the granulation tissue and the viability of the tissue in the area.

• Brand Name: BARD DEBAKEY FABRIC
• Type of Device: POLYESTER VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5667542
• MDR Text Key: 45570171
• Report Number: 2020394-2016-00453
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K770235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 007831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR