MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT; SUTURE, ABSORBABLE, SYNTHETIC

Device Problem Material Erosion (1214)

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Seroma (2069); Urinary Tract Infection (2120); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 08/1/2018.(b)(4).Citation: female pelvic medicine & reconstructive surgery.2012; 18(5).Doi: 10.1097/spv.0b013e3182673772.

Event Description

It was reported via journal article: "title: abdominal sacral hysteropexy: a pilot study comparing sacral hysteropexy to sacral colpopexy with hysterectomy" author: kristina cvach, md,* roxana geoffrion, md,þ and geoffrey w.Cundiff, md.Citation: female pelvic medicine & reconstructive surgery.2012; 18(5).Doi: 10.1097/spv.0b013e3182673772.Treatment of pelvic prolapse with uterine conservation using the sacral hysteropexy may be associated with less patient morbidity but has uncertain subjective and objective outcomes.The objectives of this ambispective (retrospective/prospective) study was to compare abdominal sacral hysteropexy (ash) with abdominal sacral colpopexy/total abdominal hysterectomy (asc/tah).A total of 27 patients were eligible for the study including 18 patients who underwent ash (age range: 28 to 71 years old; bmi: 19.71 to 35.27) and 9 subjects who underwent asc/tah (age range: 37 to 66 years old; bmi: 21.09 to 29.30).During the procedure for ash, a 15 × 15 cm piece of large-weave gynecare gynemesh ps mesh (ethicon) is used to fashion two 4.5- to 5-cm-wide strips of mesh; one is bisected for a distance of 5 cm to produce a y-configuration for the anterior mesh.The anterior mesh arms are passed through the broad ligament windows and attached to the cervix and pubocervical fascia using interrupted pds 2-0 sutures (ethicon).The posterior mesh is attached to the distal rectovaginal fascia using transverse-interrupted pds 2-0 sutures.The mesh is attached as far distally as possible to provide maximum support and elevation to the posterior wall and the apical compartment.A halban culdoplasty is performed using pds 2-0 sutures to obliterate the cul-de-sac and prevent entrapment of bowel under the mesh.Once the sacral dissection has exposed the anterior longitudinal ligament and middle sacral vessels, the proximal ends of the 2 mesh strips are attached to the sacral promontory using 2 ethibond 2-0 sutures (ethicon) to provide elevation of the uterus without tension.The peritoneum is closed over the mesh using vicryl 3-0 suture (ethicon).During the procedure for asc/tah, after abdominal hysterectomy with single-layer vault closure using vicryl 2-0 sutures, further dissection of the bladder off the pubocervical fascia is performed.The rectovaginal space is entered as for ash.Two 4.5- to 5-cm-wide strips of gynecare gynemesh ps mesh are attached to the pubocervical and rectovaginal fascia, respectively, using transverse-interrupted pds 2-0 sutures.Halban culdoplasty, sacral dissection, and attachment of the sacral ends of the mesh strips is performed as for ash.Reported complications included urinary tract infection (n-1), ileus (n-2), superficial wound dehiscence (n-1), and seroma (n-1).In the ash group, reported complications included isolated anterior compartment failure (n-8), isolated posterior compartment failure (n-1), failure in both compartments (n-2), and recurrent prolapse (n-1) which required posterior repair with fascial replacement.In the asc/tah group, reported complications included bleeding at rectocele repair (n-1) which required blood transfusion, rectus sheath hematoma (n-1) which required blood transfusion, mesh erosion (n-3) which were managed successfully with surgical excision of the mesh via a vaginal approach (n-2), isolated posterior compartment failure (n-2), failure in both compartments (n-1).It was concluded that ash may reduce the risk of mesh erosion compared to asc/tah.The trade-offs are the potential increased risk of recurrent anterior compartment prolapse.The study has provided valuable data, which have helped us refine the surgical technique and improve preoperative assessment strategies.

• Brand Name: VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7740165
• MDR Text Key: 115720466
• Report Number: 2210968-2018-74815
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GYNEMESH, PDS II, ETHIBOND SUTURE
• Patient Outcome(s): Required Intervention