MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-06-03 for DYNAMIC Y STENT M00570680 manufactured by Willy Ruesch Gmbh.
[4680803]
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) 2014. According to the complainant, the stent was implanted to treat a malignant lesion and an ulcer in the left main stem bronchus. Reportedly, the patient? S anatomy was tortuous and was not dilated prior to stent placement. During the procedure, the physician was able to deploy the stent. The physician noted that the patient was getting air around the stent but not through it. Following deployment, the ulcer started bleeding in the distal trachea and blood started to fill up around the bottom of the stent blocking the air flow. The physician performed suction to the bleed and then chose to remove the stent. The physician was unable to remove the stent with both rigid and flexible graspers. The physician performed a tracheotomy to remove the stent and refine the airway to reestablish normal airflow. Following the procedure, the patient was in the intensive care unit with close monitoring. Reportedly, the bleeding has been resolved.
Patient Sequence No: 1, Text Type: D, B5
[11817128]
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown. However, the complainant stated that the device was used prior to the expiration date (b)(6). Tracheotomy surgery performed. Reported event of stent positioning problem. Reported event of stent difficult to remove. 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 | 3005099803-2014-02144 |
| MDR Report Key | 3845094 |
| Report Source | 05,07 |
| Date Received | 2014-06-03 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-05-12 |
| Date Mfgr Received | 2014-05-12 |
| Date Added to Maude | 2014-06-03 |
| 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. INGRID MATTE |
| 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 | 2014-06-03 |
| Model Number | M00570680 |
| 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 | 1. Required No Informationntervention | 2014-06-03 |