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

Device Problems Loose or Intermittent Connection (1371); Patient-Device Incompatibility (2682)

Patient Problem Granuloma (1876)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Citation: laryngoscope.2010; 120:731 733.Doi: 10.1002/lary.20826.(b)(4).

Event Description

It was reported via journal article: "title: adjustable laterofixation of the vocal fold in bilateral vocal fold paralysis" authors: waleed f.Ezzat, md; mohammed shehata, md; ihab kamal, md; magdy amin riad, md, frcs citation: laryngoscope.2010; 120:731 733.Doi: 10.1002/lary.20826 the objectives of this prospective case study was to describe a modification of vocal fold (vf) laterofixation in patients with bilateral vf paralysis (vfp), which allows adjusting the sutures tension according to voice and airway patency in the first post-operative day.A total of 21 patients with recent bilateral vfp were treated by the modified laterofixation technique in ain-shams university hospitals between may 2007 and february 2009.There were 8 male patients and 13 females were included.The median age of the group was 36 years.During the surgical procedure, the trocars of the cannula were removed and a prolene 2 0 suture on a straight, short needle was introduced into the lower cannula from outside.Once the edge of the needle was recognized under the operative microscope it was grasped by a regular microlaryngeal needle holder.It was then redirected to pass through the upper cannula from within the airway to the outside.A single thread formed a loop around the vocal fold.With the two ends of the suture now being external, the loop was pulled until the vocal fold was sufficiently lateralized.The ends of the suture were tied externally over a piece of gauze and the patient was awakened.The next day when the patient was fully conscious and under flexible endoscopic laryngoscopy, the suture was tied to a suitable tension according to the voice and airway preferences of the patient.The suture was then buried after six to eight knots were made.Reported complications included loosening of the knots and loss of suture tension (n-1) which required revision surgery and procedure failed to achieve a satisfactory laryngeal airway (n-1), in whom decannulation of the tracheotomy was not achieved.At 6 months post-surgery, other reported complications included vf movements (n-2) in which the sutures were removed under local anesthesia by reopening the neck incision and cutting the knot with removal of the stitch, lateral migration of the looped suture (n-1), and granuloma (n-1).It was reported that in patients where no movement was observed, the suture was left in situ for at least 1 year, pending definitive procedures.It was concluded that the modified laterofixation technique is a reliable first line treatment for recent bilateral vfp.

• 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: 7651563
• MDR Text Key: 112838390
• Report Number: 2210968-2018-73946
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2018
• 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