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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC

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ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(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. Attempts are being made to obtain 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 ethicon products (prolene suture, vicryl suture, ethilon suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (prolene suture, vicryl suture, ethilon suture) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics. Citation: eur j vasc endovasc surg (2019) 58, 350-356; doi:10. 1016/j. Ejvs. 2019. 03. 027 - (b)(4).

 
Event Description

It was reported via journal article: "title: cutdown technique is superior to fascial closure for femoral artery access after elective endovascular aortic repair" author/s: kristian fredholm, jonas p. Eiberg, lars lönn, katja c. Vogt, henrik h. Sillesen, kim k. Bredahl. Citation: eur j vasc endovasc surg (2019) 58, 350-356; doi:10. 1016/j. Ejvs. 2019. 03. 027. The aim of this prospective, non-randomized observational study was to report on the intra-operative, in hospital, and three-month outcome of fascial closure and cutdown, and to determine risk factors for failure. From february 1, 2011 to august 31, 2014, a total of 439 groins in 225 elective endovascular aneurysm repair (evar) patients (mean age: 78 years, n= 223 males, mean bmi: 27kg/m2) were included in the study. After completion of the intervention in fascial closure group, the subcutaneous fascia (fascia lata) was exposed through a 5-7 cm oblique skin incision near the introducer sheath following langer¿s lines. A longitudinal mattress suture (prolene 2-0) (ethicon) was placed in the fascia around the sheath and guidewire. In cutdown group, after exposure, clamping and removal of the sheath, and direct arterial suture were performed (prolene 5-0) (ethicon) followed by closure of the subcutaneous tissue (coated vicryl 4-0) (ethicon) and skin (ethilon nylon 4-0) (ethicon). Intraoperative complaints included bleeding (n=18 groins in fascial closure group), and arterial thrombosis (n=9 groins in fascial closure group, n=1 groin in cutdown group) treated with cutdown and thrombectomy. In hospital results in fascial closure group are major bleeding which required reoperation (n=5 groins), arterial thrombosis (n=1) requiring thrombectomy, and minor bleeding (n=6) that resolved after manual compression. At three-month follow up, reported events in fascial closure group involved a patient (n=1) who experienced thrombosis of an iliac component 70 days post-operatively and was successfully treated with a femorofemoral bypass. Complications in cutdown group at 3-month follow up comprised of pseudoaneurysms (n=3) and all were treated conservatively. Other groin complications during the in-hospital period in fascial closure group were lymph oozing necessitating surgical revision (n=1) , lymphatic leak lasting >48 (n=12) where all was managed without surgical revision, post-operative neuralgia (n=18) where all resolved at follow up, suspected groin infections (n=6) and were managed with antibiotic treatment. In cutdown group, complications were surgical site infection requiring intravenous antibiotics (n=1). Lymphatic leak >48 h (n=11 groins) all handled without surgical revision, wound ooze (n=1) resolved after an additional skin suture and administration of antibiotics during readmission. In conclusion, fascial closure cannot be recommended as an alternative to cutdown after elective evar.

 
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Brand NameETHILON NYLON SUTURE UNKNOWN PRODUCT
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9958953
MDR Text Key189727645
Report Number2210968-2020-03031
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 03/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2020
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/14/2020 Patient Sequence Number: 1
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