MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-12-29 for POLYFLEX AIRWAY STENT SETS M00570280 7028 manufactured by Boston Scientific - Marlborough.
[2454587]
It was reported to boston scientific corporation that a polyflex airway stent was used during an airway stent placement procedure on (b)(6) 2011. According to the complainant, the indication for the procedure was treatment for tracheomalacia, not appropriate for resection. During the procedure, the stent was deployed within the trachea. However, following placement of the stent, the patient "did very poorly" and began to desaturate. The patient's heart rate decreased to the point in which it may have stopped. The physician removed the delivery system from the patient, then went down with a flexible endoscope and observed a perforation. The physician believes that upon deploying the stent, as the stent was expanding in the airway, the stent perforated the patient's airway. The physician removed the stent with rat-tooth forceps. The patient received a tracheotomy and a chest tube was inserted. The patient was then sent to surgery to repair the perforation. The current condition of the patient is "stable, guarded, neurologically intact. " the patient is on a ventilator and the physician stated that the patient "has a long road ahead of her. "
Patient Sequence No: 1, Text Type: D, B5
[9523634]
The complainant indicated that the device was disposed; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2011-04474 |
| MDR Report Key | 2391900 |
| Report Source | 05,07 |
| Date Received | 2011-12-29 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-12-05 |
| Date Mfgr Received | 2011-12-05 |
| Device Manufacturer Date | 2011-11-29 |
| Date Added to Maude | 2011-12-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUESCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Postal Code | 71394 |
| 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 | 2011-12-29 |
| Model Number | M00570280 |
| Catalog Number | 7028 |
| Lot Number | 0000011411 |
| Device Expiration Date | 2016-09-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-12-29 |