MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-08-02 for RUSCH POLYFLEX STENT KIT M00570250 7025 manufactured by Boston Scientific - Marlborough.
[1601934]
It was reported to boston scientific corporation that a polyflex tracheobronchial stent was used during a stenting procedure within the trachea on (b)(6) 2010. According to the complainant, the patient's anatomy was not tortuous and the lesion had not been predilated. After implanting the stent, the physician noted that the stent was folded upon itself. The physician cannot state when the fold happened; only that he noticed it after deployment. The physician removed the stent from the patient. The physician tried to reload the stent into the introducer system, but was unable to load it without a fold. The procedure was not completed due to this event. Radio-chemo therapy was performed on the patient with good results. 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
[8726137]
(b)(4) - patient underwent radio chemotherarpy. The complaint device has been received by the manufacturer; however, a failure analysis has not yet been completed. Upon receipt of the failure analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[15536508]
It was reported to boston scientific corporation that a polyflex tracheobronchial stent was used during a stenting procedure within the trachea on (b)(6), 2010. According to the complainant, the patient's anatomy was not tortuous and the lesion had not been predilated. After implanting the stent, the physician noted that the stent was folded upon itself. The physician cannot state when the fold happened; only that he noticed it after deployment. The physician removed the stent from the patient. The physician tried to reload the stent into the introducer system, but was unable to load it without a fold. The procedure was not completed due to this event. Radio-chemo therapy was performed on the patient with good results. 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
[15843452]
Both the stent and delivery system were returned for analysis. The returned stent corresponded to a polyflex device with a upn of (b)(4) (20mm inner diameter), while the delivery system corresponded to a polyflex device with a upn of (b)(4) (18mm inner diameter). While the delivery system did not present with any anomalies, a visual examination of the stent found that the edges were mashed and destroyed. Due to this damage, a functional evaluation could not be performed. The most probable root cause of this issue cannot be confirmed. A review of the device history record (dhr) was performed; no anomalies were noted. A search of the complaint database revealed that no similar complaints exist for the specified lot. A labeling review was performed and no deviation was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2010-03444 |
| MDR Report Key | 1779103 |
| Report Source | 07 |
| Date Received | 2010-08-02 |
| Date of Report | 2010-07-22 |
| Date of Event | 2010-06-25 |
| Date Mfgr Received | 2010-10-25 |
| Device Manufacturer Date | 2006-08-08 |
| Date Added to Maude | 2010-11-10 |
| 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 | 0 |
| 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 POLYFLEX STENT KIT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2010-08-02 |
| Model Number | M00570250 |
| Catalog Number | 7025 |
| Device Expiration Date | 2011-06-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2010-08-02 |