MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-05-22 for DYNAMIC Y STENT M00570690 manufactured by Willy Ruesch Gmbh.
[5853151]
It was reported to boston scientific corporation that a dynamic y stent was used in the trachea during a stent placement procedure performed on (b)(6) 2015. According to the complainant, the stent was being placed to treat a malignant stricture caused by metastatic lung cancer. Reportedly, the patient's anatomy was not tortuous and had not been dilated prior to stent placement. During the procedure, the physician trimmed the dynamic y stent to the desired length. The physician grasped the stent with freitag forceps and attempted to pass the stent through the vocal cords. However, under direct visualization with the glide scope, the physician noted that the back side of the stent had torn. The stent was removed and the procedure was completed with another dynamic y stent. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
[13401443]
(b)(4). The complainant indicated that the device was 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 | 3005099803-2015-01445 |
| MDR Report Key | 4792591 |
| Report Source | 05,07 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-09 |
| Date of Event | 2015-05-08 |
| Date Mfgr Received | 2015-05-09 |
| Device Manufacturer Date | 2014-01-23 |
| Date Added to Maude | 2015-05-22 |
| 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. NANCY CUTINO |
| 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 | 2015-05-22 |
| Model Number | M00570690 |
| Lot Number | 0000013501 |
| Device Expiration Date | 2018-11-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLY RUESCH GMBH |
| Manufacturer Address | WILLY RUESCH STRASSE 4-10 KERNEN 71394 71394 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-22 |