MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Blood Loss (2597); Complete Heart Block (2627); Thromboembolism (2654); Not Applicable (3189); No Code Available (3191); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The information was reported with multiple events through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Procedure? does the surgeon believe that the ethicon product (prolene suture) involved caused and/or contributed to the postoperative complications described in the article ? does the surgeon believe there was any deficiency with the ethicon suture product prolene used in this procedure? please confirm , aside from the 3 reported patients with post-operative bleeding or pericardial effusion, what are the diagnoses that leads to homologous blood transfusions (n-39) reported the article.

Event Description

It was reported in a journal article entitled: freedom solo valve: early- and intermediate-term results of a single centre¿s first 100 cases.Authors: pierre oses, jean-philippe guibaud, nicolas elia, gilbert dubois, guillaume lebreton, mathieu pernot, xavier roques.Citation: european journal of cardio-thoracic surgery.2011; 39: 256 261.Doi: 10.1016/j.Ejcts.2010.04.038.The freedom solo (fs) aortic valve is a bovine pericardial stentless valve, which requires only one suture line.The aim of the author¿s single-center retrospective study was to assess post-operative and intermediate-term hemodynamic results of the first 100 consecutively implanted valves.A total of 100 patients (39 male and 61 female; age range: 42 to 86 years old) underwent aortic valve replacement with a freedom solo from november 2006 to january 2008.During the surgical procedure, the fs valves were implanted with a continuous supra annular suture line technique using 3 prolene 4-0 running sutures starting at the base of each sinus valsalva and proceeding to the top of the commissures.Reported complications included complete atrio-ventricular block (n-3) which required pacemaker implantation before hospital discharge, post-operative bleeding or pericardial effusion (n-3) which required re-intervention and homologous blood transfusions, minor thrombo-embolism (n-3) which required anti-coagulants (n-2) and anti-platelet therapy (n-1), and mild aortic regurgitation (n-3) which were asymptomatic and remained stable at 12 months post-operatively.It was concluded that the fs stentless bioprosthesis appears to be an excellent option for avr in older and often sicker patients.Echocardiographic data showed that the hemodynamic performance, particularly in small diameters, of the fs valve is excellent and allow us to use it by first intention in this population.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7625617
• MDR Text Key: 111898933
• Report Number: 2210968-2018-73633
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133356
• 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: 06/04/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/21/2018
• 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