MAUDE Adverse Event Report: BIORESORBABLE AIRWAY SPLINT; PROSTHESIS, TRACHEAL, EXPANDABLE

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

Patient Problems Death (1802); Edema (1820); Respiratory Acidosis (2482); Respiratory Failure (2484)

Event Date 08/02/2019

Event Type  Death  

Event Description

We are writing to report the death of pt (b)(6), who died on (b)(6) 2019 here at the (b)(6).Pt (b)(6) was implanted with bioresorbable airway splints on (b)(6) 2018.(b)(6) had splints implanted while on ecmo on (b)(6) 2018.Her chest remained open post-operatively, and on (b)(6), (b)(6) presented with an intrathoracic air leak not addressed by her existing chest tubes.It was presumed that (b)(6) had an air-leak from the dissection required to placed her splints.An add'l chest tube was placed on (b)(6) and removed on (b)(6) with no re-appearance of the air leak.This sae was determined to be expected and definitely related to the dissection required to place the splints (not the splints themselves).(b)(6) was decannulated from ecmo on (b)(6) 2018 and did not require any further courses of ecmo.Post-operative course at (b)(6): (b)(6) was making slow but steady progress until (b)(6) 2018, experienced an acute decompensation episode and underwent airway dilation.She had severe respiratory acidosis that eventually stabilized and was able to wean back to her baseline vent settings.She continued to have persistent issues with dynamic collapse and malacia of trachea distal to the tracheal splint (near her pseudo-carina) and this abnormality continued to cause intermittent but significant airway collapse during times of stress such as infection or fluid overload.Death at (b)(6): from (b)(6) 2018 until her death on (b)(6), (b)(6) remained relatively stable in an icu setting.She was able to transition to a home ventilator for up to two weeks at a time, was able to sit unassisted, and was very interactive with her parents and caregivers.She required occasional removal of granulation tissue at the distal end of her tracheostomy tube.Toward the end of (b)(6), (b)(6) began experiencing further respiratory deterioration in her status.A ct scan on (b)(6) 2019 demonstrated a patent airway during both inspiration and expiration and severe distal airway disease.On (b)(6) 2019, (b)(6) again underwent removal of granulation tissue.Postoperatively she developed edema, respiratory acidosis and deoxygenation.She required increase in ventilator settings, and was given steroids, initiation of heliox and ino.Longer and shorter tracheostomy tubes were tried.Despite these interventions, co2 levels remained elevated with severe acidosis.The decision was made to transition to comfort care and support was withdrawn with parents at bedside.(b)(6) died early on (b)(6) 2019.The parents declined autopsy.The cause of death is thought to be acute on chronic respiratory failure secondary to severe parenchymal disease (in her single lung).(b)(6) was (b)(6) at the time of death.

• Brand Name: BIORESORBABLE AIRWAY SPLINT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• MDR Report Key: 8911041
• MDR Text Key: 154909137
• Report Number: MW5089156
• Device Sequence Number: 0
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 18 MO