MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RESORBABLE IMPLANTS: 0.5 MM MESH; PLATE, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 0.5-mm thick polymax resorbable mesh/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: yu p., clayman g., walsh g., (2010)long-term outcomes of microsurgical reconstruction for large tracheal defects, cancer volume 117(4) , pages 802-808(usa).This retrospective study aims to report the authors experience with microsurgical reconstructions performed in 7 patients with long-term follow-up and long-term outcomes.Between may 2004 and april 2008, a total of 7 patient (4 females, 3 males) underwent microsurgical tracheal reconstruction to preserve the larynx and avoid a mediastinal tracheostomy.During the procedure, semi-rigid support was provided by a 26-mm hemashield vascular graft (boston scientific) , in 2 patients, a 20-mm polytetrafluoroethylene (ptfe)ring vascular graft in 3 patients, and a porous high-density polyethylene (medpor) prosthesis (porex corporation) in 1 patient.The softness and inadequate diameter of the hemashield graft made it necessary to open the graft longitudinally and reinforce it with a sheet of 0.5-mm thick polymax resorbable mesh (synthes, paoli, pa).The ring-enforced ptfe graft had the rigidity needed, but the maximum diameter available (20 mm) was too small.Therefore, the ptfe grafts were also longitudinally opened and reinforced with 3 strips (5 mm wide) of 0.8-mm thick polymax mesh rings with a diameter of 30 mm.Patients were followed in the clinic at regular intervals after discharge.The following complications were reported as follows: one patient died from unrelated causes at 2 years(n=1).(patient 6): a (b)(6) year old male patient died from myocardial infarction.(polymax was not used in this patient.(patient 1): a (b)(6) year old female died from a newly diagnosed cholangiocarcinoma 4 years after tracheal reconstruction at the time of last follow-up.(patient 3) a (b)(6) year old female had air leak at the proximal anastomosis.Ptfe graft exposure to lumen through the leak and required operative intervention and required operative intervention.Also had congestive heart failure.(patient 4) a (b)(6) year old male had air leak at the proximal anastomosis.Ptfe graft exposure to lumen through the leak and required operative intervention and required operative intervention.Patient required a delayed tracheostomy due to respiratory compromise and were never decannulated.Died from respiratory failure 2 months after surgery.(patient 7) a (b)(6) year old female had air leak at the proximal anastomosis and treated with placement of a catheter connected to a pleurovac and healed within 1 to 3 weeks.This report is for an unknown synthes 0.5-mm thick polymax resorbable mesh.It captures a (b)(6) year old female had air leak at the proximal anastomosis and treated with placement of a catheter connected to a pleurovac and healed within 1 to 3 weeks.A copy of the literature article is being submitted with this medwatch.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - RESORBABLE IMPLANTS: 0.5 MM MESH
• Type of Device: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11592957
• MDR Text Key: 243119080
• Report Number: 2939274-2021-01624
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2021

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: 03/04/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR