MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-03-25 for RUSCH TRACHEAL BRONCHIAL Y STENT M00570690 manufactured by Boston Scientific - Marlborough.
[1436014]
It was reported to boston scientific corporation that a dynamic y stent was attempted to be placed within the right main stem of the bronchus of a cancer patient on (b) (6) 2010 ((b) (6) female; weight unknown). According to the complainant, the stent was being placed to treat a malignant tumor that was occluding the patient? S airway. The patient was reported to be ok at time of procedure, but had been unstable throughout the prior day. The lesion was predilated; however the right main stem bronchus was still partially occluded by the tumor. Per the directions for use, the stent length was modified prior to the procedure. Approximately 2 cm of the tracheal length and 2 cm of the left main stem length were cut off. These modifications were performed using measurements taken under fluoroscopy and direct visual assessment with rigid scope. Following these modifications, the stent was implanted under the aid of fluoroscopy via laryngoscope and freitag forceps. The stent appeared to be successfully placed. Upon removal of the forceps; however, the stent migrated approximately 2 cm towards the trachea, thereby obstructing the patient? S airway. No significant resistance had been noted during the removal of the forceps; however, the forceps did contact the stent and could have pulled it slightly out of position. The physician was unable to confirm if it was the forceps or the patient? S anatomy that caused the stent to migrate. Several attempts were made attempting to put the stent back in position. When it was determined that repositioning the stent was not possible, several attempts were then made with various grasping forceps to try and remove the stent. During these attempts, the patient? S airway became increasingly occluded with blood and tissue. The physician was unable to explain why the bleeding occurred at the level that it did, but the physician did state that the more retrieval attempts he attempted the more the bleeding occurred. Suction and irrigation were used to treat the bleeding; however, the bleeding continued and made it very difficult to visualize the stent. The physician was unable to remove the stent and the patient expired. No autopsy was performed, but the physician? S assessment of the cause of death was that the stent blocked the airway causing the patient to suffocate.
Patient Sequence No: 1, Text Type: D, B5
[8484338]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. 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 | 3005099803-2010-01413 |
| MDR Report Key | 1640189 |
| Report Source | 05,07 |
| Date Received | 2010-03-25 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-03-04 |
| Date Mfgr Received | 2010-03-04 |
| Date Added to Maude | 2010-03-25 |
| 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 | MR. 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 | RUSCH TRACHEAL BRONCHIAL Y STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2010-03-25 |
| 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. Death | 2010-03-25 |