MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-01-06 for DYNAMIC Y STENT M00570690 manufactured by Boston Scientific - Marlborough.
[2417659]
It was reported to boston scientific corporation that a dynamic y stent was attempted to be implanted within the patient's trachea on (b)(6), 2011 during a bronchoscopy procedure. According to the complainant, the patient has tracheomalacia. During the procedure, the physician attempted to implant the stent within the patient's trachea and inadvertently deployed it within the patient's esophagus. Reportedly, the patient's anatomy was not tortuous but the physician noted that he was "unable to position the patient's head in such a way as to give him straight access through the vocal cords and into the trachea. " subsequently, a gastroenterologist removed the stent using rat tooth forceps through an egd scope. Due to the patient's difficult anatomy, no further attempts were made to implant the dynamic y stent. Reportedly, the physician planned to place a smaller stent later that week. It was reported that the patient experienced edema as a result of the numerous attempts made to pass the stent through the vocal cords; however, the patient condition post procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[9599244]
(b)(4):the complainant was unable to provide the suspect device lot number; therefore, the device manufacture and expiration dates are unknown. However, it was reported that the device was used prior to its expiration date. (b)(4). 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 there is any further relevant information, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2011-04619 |
| MDR Report Key | 2402565 |
| Report Source | 05,07 |
| Date Received | 2012-01-06 |
| Date of Report | 2011-12-15 |
| Date of Event | 2011-12-15 |
| Date Mfgr Received | 2011-12-15 |
| Date Added to Maude | 2012-01-06 |
| 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 | 2012-01-06 |
| Model Number | M00570690 |
| 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. Required No Informationntervention | 2012-01-06 |