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

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

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.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that 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 the ethicon product prolene suture used in this procedure? citation: ann thorac surg 2015; 99:826¿30; http://dx.Doi.Org/10.1016/j.Athoracsur.2014.09.046.(b)(4).

Event Description

It was reported via a journal article title: aortic valve replacement through right minithoracotomy: is it really biologically minimally invasive? author(s): elisa mikus, md, simone turci, md, simone calvi, md, massimo ricci, md, luca dozza, ms, and mauro del giglio, md, phd.Citation: ann thorac surg 2015; 99:826¿30; http://dx.Doi.Org/10.1016/j.Athoracsur.2014.09.046.The purpose of this study was to present the authors¿ experience with minimally invasive aortic valve replacement (miavr), whether the minimally invasive surgical approach corresponds to a minimal biological damage, and which are the key factors making a cardiac operation biologically less invasive.Between jan2010 and mar2014, 206 patients (n=129 male and n=77 female; mean age of 71.5±12.0 years) with diagnosis of either degenerative aortic valve stenosis, aortic regurgitation or mixed, underwent miavr.In the procedure, the prosthetic valve was implanted with three running 2/0 120-cm prolene sutures.The ascending aorta incision was closed with double 5/0 prolene sutures.Postoperatively, there were 3 cases of wound dehiscence or infection among the subjects.The advantage of this surgical technique includes lower incidence of wound complications, especially in high-risk, obese, diabetic or osteoporotic patients.Miavr-rt can be biologically minimally invasive, rather than only an aesthetic choice, as long as low operative times and total central cannulation can be guaranteed; at these conditions, it provides a feasible and promising alternative to conventional valve surgery.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 7610924
• MDR Text Key: 111429629
• Report Number: 2210968-2018-73529
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/25/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/18/2018
• 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