MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-03 for DYNAMIC Y STENT M00570690 manufactured by Boston Scientific - Marlborough.
[3043545]
Note: this report pertains to one of two devices used during the same procedure. Manufacturer report # 3005099803-2012-05629 and 3005099803-2012-05630 address these devices. It was reported to boston scientific corporation that two dynamic y stents were attempted to be placed during a pulmonary procedure performed on (b)(6) 2012. According to the complainant, the indication for the stent placement was treatment for a malignant occlusion at the distal trachea up to the voice box. During the procedure, the physician could not get the stent (3005099803-2012-05629) down, due to the occlusion and tortuous anatomy. A second dynamic y stent (3005099803-2012-05630) was obtained, when trying to place the second stent, the physician released the forceps which caused the stent to drop and obstruct the patient's airway. The patient's stats starting dropping due to the airway being blocked by the stent, an emergency tracheotomy was immediately performed. There were no attempts made to remove the stent prior to performing the tracheotomy due to drop in the patent's stats. The stent was removed after the tracheotomy was performed. The patient was put on a ventilator for 4-5 days and then another dynamic y stent was successfully placed through tracheotomy site. The physician indicated that it was very difficult to place a stent, due to the patient anatomy (tumor location) and edema that occurred because of multiple attempts to place a stent. The edema was not treated and left to resolve on its own. The patient's condition was reported to be stable post procedure.
Patient Sequence No: 1, Text Type: D, B5
[10260033]
(b)(4). The complainant indicated that the device was disposed of, 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 | 3005099803-2012-05629 |
| MDR Report Key | 2854971 |
| Report Source | 05,07 |
| Date Received | 2012-12-03 |
| Date of Report | 2012-11-08 |
| Date of Event | 2012-11-08 |
| Date Mfgr Received | 2012-11-08 |
| Device Manufacturer Date | 2012-03-06 |
| Date Added to Maude | 2012-12-03 |
| 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 | DYNAMIC Y STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2012-12-03 |
| Model Number | M00570690 |
| Lot Number | 0000012081 |
| Device Expiration Date | 2017-01-31 |
| 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 | 2012-12-03 |