MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCL0024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Airway Obstruction (1699); Edema (1820); Unspecified Infection (1930); Organ Dehiscence (2502); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(tracheostomy and transient vocal cord immobility) title modified single-stage segmental cricotracheal resection source eur arch otorhinolaryngol (2018) 275:139¿146.Date of publication: 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after utilizing the suture for repair of cricotracheal stenosis following a laryngosternopexy surgical procedure, there were adverse events experienced.These included acute airway obstruction requiring emergency tracheostomy through the anastomosis, a tracheal dehiscence, laryngeal edema with airway obstruction, superficial wound infections, neck abscesses, and transient vocal cord immobility.It was also reported that the sutures were tied together at the midline of the anterior portion of the anastomosis.

• Brand Name: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7846316
• Report Number: 1219930-2018-04852
• Device Sequence Number: 11086124
• Product Code: GAM
• UDI-Device Identifier: 20884521130415
• UDI-Public: 20884521130415
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VLOCL0024
• Device Catalogue Number: VLOCL0024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention