MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-11-09 for DYNAMIC Y STENT M00570690 manufactured by Boston Scientific - Marlborough.
[18985693]
It was reported to boston scientific corporation that a dynamic y stent was used during a stent placement procedure on (b)(6) 2011. According to the complainant, the patient's anatomy was particularly difficult, in that the anatomy was very tight just above the vocal chords. The lesion was in the trachea, just above the carina. No dilatation was able to be performed due to the challenging nature of the patient's anatomy. During the procedure, the user had difficulty getting the two bronchial limbs to come together using the freitag forceps. Reportedly, the user did not cut the left bronchial limb of the stent. The stent reached the vocal chords, but was not able to pass through the vocal chords. As the stent was unable to be positioned correctly, the dynamic y was removed and the procedure was successfully completed with a polyflex stent. There were no patient complications reported as a result of this event. The patient condition post procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[19037863]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18 reported issue of stent difficulty crossing lesion. Reported issue of stent placement/positioning problem. The complainant indicated that the device has been disposed and will not be returned for evaluation; 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 | 3005099803-2011-03824 |
| MDR Report Key | 2329360 |
| Report Source | 05,07 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-10-14 |
| Date of Event | 2011-10-14 |
| Date Mfgr Received | 2011-10-14 |
| Device Manufacturer Date | 2011-08-02 |
| Date Added to Maude | 2011-11-09 |
| 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 | 2011-11-09 |
| Model Number | M00570690 |
| Lot Number | 0000011291 |
| Device Expiration Date | 2016-06-30 |
| 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 | 2011-11-09 |