MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT; CLIP, IMPLANTABLE

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

Patient Problems Abscess (1690); Anemia (1706); Hematoma (1884); Hemorrhage/Bleeding (1888); Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? (b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Events related to 0-vicryl suture captured via 2210968-2021-04750.Events related to pds sutures captured via 2210968-2021-04751.Citation: female pelvic medicine & reconstructive surgery.2021; 27 (1): e223¿e226.Doi: 10.1097/spv.0000000000000898.

Event Description

Title: short-term outcomes of vaginal hysterectomy at the time of robotic sacrocolpopexy.The aim of this study is to describe our patient population who underwent total vh with concomitant robotic-assisted sacrocolpopexy and to discuss perioperative outcomes and adverse events.Between july 2012 to july 2017, a total of 209 women (mean age = 59 years; mean bmi = 29) underwent total vaginal hysterectomy (vh) with concomitant robotic sacrocolpopexy (rsc) for stages ii to iv pelvic organ prolapse.Surgery was performed using 0-vicryl suture (ethicon) upon closing the vaginal cuff.Polydioxanone (pds) sutures (ethicon) was used in 76 patients or competitor device in 133 patients for suturing the y-mesh and also affixing the posterior arm of the mesh.The mesh was reperitonealized using a pds suture (ethicon) using a lapra-ty (ethicon) at the end of the closure.Reported complications included recurrent prolapse (n=20), with ba or bp greater or equal to 0, which required reoperations in 3 patients: one patient required anterior repair, a second patient required posterior repair, and a third patient required apical suspension with a sacrospinous ligament fixation in addition to an anterior and posterior repair; symptomatic anemia or bleeding (n=2) requiring blood transfusion.Both patients were stable after transfusion of 2 u packed red blood cells.All blood loss was thought to have occurred during surgery as hemoglobin normalized after transfusion.Both patients were discharged home after transfusion without further complications; pelvic hematoma (n=1) who presented after discharge on postoperative day 4 during bridging from lovenox to coumadin; urinary tract infections (n=18); postoperative venous thromboembolism (n=5), 3 were diagnosed with pulmonary embolism.One of these patients had new onset atrial fibrillation; postoperative febrile morbidity (n=9); pelvic collection/abscess (n=4), one patient required image-guided percutaneous drainage and antibiotic therapy.The second patient was treated with intravenous antibiotics exclusively, and follow-up computed tomography scan showed resolution.The third patient required exploratory laparotomy for septic shock where an infected hematoma was discovered and evacuated.Because of concern for infected mesh, it was removed.The explanted mesh grew escherichia coli.Mesh was removed robotically in the fourth patient who was septic from epidural abscess.This patient was immunocompromised; because of high-dose steroids, she required a rheumatoid arthritis flair.Microbiology from the infected mesh confirmed enterococcus faecalis; mesh exposure at the vaginal apex (n=4) which required reoperation.The majority of these patients were symptomatic, with complaints of bleeding and increased discharge.In conclusion, vaginal hysterectomy at the time of rsc may increase the risk of infection and mesh exposure compared with procedures without concomitant hysterectomy.

• Brand Name: LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11842925
• MDR Text Key: 265499332
• Report Number: 2210968-2021-04752
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/02/2021
• 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
• Patient Outcome(s): Required Intervention