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

Device Problem Insufficient Information (3190)

Patient Problems Complete Heart Block (2627); Not Applicable (3189)

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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 products used in this procedure? citation: ann thorac surg.2014; 97: 666 72.(b)(4).

Event Description

It was reported via journal article title: modified single-patch compared with two-patch repair of complete atrioventricular septal defect authors: shinya ugaki, md, phd, nee s.Khoo, mbchb, david b.Ross, md, ivan m.Rebeyka, md, and ian adatia, mbchb citation: ann thorac surg.2014; 97: 666 72.Doi: http://dx.Doi.Org/10.1016/j.Athoracsur.2013.09.084 the authors compared the outcomes of modified single-patch and two-patch surgical repair of complete atrioventricular septal defect (cavsd) on left ventricular outflow tract (lvot) diameter and on left atrioventricular valve (lavv) coaptation.The authors reviewed retrospectively post-operative 2-dimensional echocardiograms of all cavsd patients who underwent modified single-patch or two-patch repair between 2005 and 2011.A total of 51 patients (16 male infants and 35 female infants) underwent cavsd repair at a median age of 4 months (age range: 1 to 9 months).Of which 29 patients underwent single-patch while 22 patients underwent the two-patch technique.During the surgical procedure for the modified single-patch technique, the zone of apposition (lavv cleft) was closed with a series of interrupted prolene sutures.Then, a series of horizontal mattress pledgeted prolene sutures was passed through the right side of the ventricular septal crest and through the base of the lavv before being passed through a trimmed bovine pericardium.The sutures were then tied to close the ventricular component, with the lavv sandwiched between the bovine patch and the crest of the ventricular septum.The bovine pericardial patch was secured to the rim of the ostium primum defect with continuous prolene suture, leaving the coronary sinus draining normally to the right atrium.In the two-patch repair technique, the zone of apposition (lavv cleft) was approximated with interrupted prolene sutures before the atrial septal defect was closed.In the modified single-patch technique, reported complications involved 1 patient with complete antrioventricular block which required pacemaker implantation, it was concluded that the modified single-patch repair was performed with significantly shorter bypass time and myocardial ischemic time.

• 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: 7634661
• MDR Text Key: 112282564
• Report Number: 2210968-2018-73744
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/01/2018

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
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/25/2018
• 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
• Patient Outcome(s): Required Intervention