MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-24 for POLYFLEX AIRWAY STENT SETS M00570140 7014 manufactured by Boston Scientific - Galway.
[75890991]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). According to the complainant, the suspect device has been retained and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[75890992]
It was reported to boston scientific corporation on may 1, 2017 that a polyflex airway stent was implanted through previously placed nitinol uncovered stent to try to prevent further ingrowth of granulation tissue in the trachea during a stent placement procedure performed on (b)(6) 2016. The patient had received 2 or 3 previous uncovered nitinol stents over the past 15 years to treat an underlying condition of benign focal tracheomalacia following a thyroidectomy. For the past 5 years the patient had been developing worsening stridor. The previous stents had completely broken down and granulation tissue was nearly totally occluding the airway. Debridement of the tissue was performed 4 times but the tissue granulation would recur within weeks. Reportedly, following the implantation of the polyflex stent the patient experienced near complete symptom control. According to the complainant, the patient experienced a rapid onset of breathlessness and stridor on (b)(6) 2017. An elective bronchoscopy was performed on (b)(6) 2017 and the physician noted that the inner silicon lining of the stent appeared to have separated from the outer mesh and was partially obstructing the stent. The physician used a microdebrider to remove the protruding material, the lining was broken into small pieces and suctioned from the patient, and the stent's lumen patency was restored. Reportedly, the stent is scheduled to be removed on (b)(6) 2017. The patient's condition at the conclusion of the procedure was reported to be stable. According to the physician, he was not sure if the damage to the stent lining was a device malfunction or whether it could have been due to the inhaled nebulized n-acetylcystein (400 mg bd) the patient was prescribed as part of routine secretion management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-01461 |
| MDR Report Key | 6589162 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-01 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2017-08-07 |
| Date Added to Maude | 2017-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLEX AIRWAY STENT SETS |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2017-05-24 |
| Returned To Mfg | 2017-06-23 |
| Model Number | M00570140 |
| Catalog Number | 7014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-24 |