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

Catalog Number PROLSUTUNK

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).The events were reported through a journal article.No specific patient information regarding the events have been provided and it is unknown if the events have been previously reported.No product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).

Event Description

It was reported in a journal article entitled: continuous versus interrupted technique of ventricular septal defect (vsd) closure in total correction for tetrology of fallot pertaining to residual vsd.Authors: riffat tanveer, arif-ur-rehman khan, tariq azam siddiqi, sohail siddique, ameena nasreen, salman-ur-rehman and saad badar citation: vol.60, no.4, april 2010.The aim of this randomized control study was to analyze the outcome of continuous versus interrupted closure technique of ventricular septal defect (vsd) closure in tetrology of fallot (tof) with reference to postoperative residual vsd after total correction.Between january 2008 to december 2008, 60 patients with tof were included in the study.There were 20 females and 40 males with ages ranging between 4 to 18 years old.During the procedure, 30 patients¿ vsd was closed with 5/0 proline continuous double ended suture while in remaining 30 (50%) patients vsd was closed with interrupted 5/0 prolene double ended sutures.Postoperative echocardiography was done in all patients as a routine on second postoperative day, to document residual vsd.Postoperative echocardiography showed residual vsd in 05 (8.3%) patients at postero-inferior rim of vsd.Of these 05 cases, in four vsd had been closed with continuous 5/0 proline double ended sutures, and one had vsd closed with interrupted 5/0 double ended sutures.Suturing techniques may play a significant role in occurrence of residual vsd.In all patients leak was at postero-inferior area of the septal patch.In conclusion, residual vsd is common with continuous suturing repair technique as compared to interrupted suturing technique of vsd closure.This is perhaps because of poor myocardium quality and higher rv pressures in our late presenting patients compared to western population of patients.Small (less than 05 mm size) residual vsd can be treated conservatively if haemodynamically stable.No further information is available.

• 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: 7606998
• MDR Text Key: 111296503
• Report Number: 2210968-2018-73508
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: PROLSUTUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• 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