MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2015-03-12 for DYNAMIC Y STENT M00570690 manufactured by Willy Ruesch Gmbh.
[17298614]
It was reported to boston scientific corporation that a dynamic y stent was to be used in the tracheobronchial junction during an airway stenting procedure performed on (b)(6) 2015. According to the complainant, the stent was to be implanted to treat a stenosis in the tracheobronchial junction. Reportedly, the patient's anatomy was not tortuous and had been pre-dilated. There was no visible damage noted to the stent prior to the procedure. During the procedure, the physician experienced difficulty positioning the stent across the stricture using the delivery forceps. Once the stent was in position, the physician was unable to withdraw the forceps from the stent and the stent was removed along with the forceps. Outside the patient, the physician noted that both of the stent? S bronchial limbs had ruptured. According to the physician, the stent damage was possibly due to the sharp ends of the forceps being used. The procedure was completed with a smaller stent and different forceps. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[17455699]
(b)(4) ruptured stent limbs. 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 | 3005099803-2015-00534 |
| MDR Report Key | 4593342 |
| Report Source | 00,01,05,07 |
| Date Received | 2015-03-12 |
| Date of Report | 2015-02-18 |
| Date of Event | 2015-02-18 |
| Date Mfgr Received | 2015-02-18 |
| Device Manufacturer Date | 2013-09-09 |
| Date Added to Maude | 2015-03-12 |
| 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 | 2015-03-12 |
| Model Number | M00570690 |
| Lot Number | 0000013321 |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-03-12 |