MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-09-04 for POLYFLEX AIRWAY STENT M00570320 7032 manufactured by Boston Scientific Corporation.
[1175990]
It was reported to boston scientific corporation that a polyflex stent was used during an airway stent placement performed on (b)(6) 2009, (age reported as 18+). According to the complainant, the stent was deployed at the carina. However, the stent was crimped and did not fully expand at the distal end. The pt's anatomy influenced the deployment of the stent because the anatomy was oval shaped instead of round. The stent was repositioned by pulling it approx 2 cm proximally. Following 15 mins post stent placement, the stent still had not fully expanded. The physician made the decision to remove the stent from the pt and abort the procedure. To date, the procedure has not been rescheduled. There were no pt complications reported as a result of this event. The pt's condition at the conclusion of the procedure was reported to be satisfactory.
Patient Sequence No: 1, Text Type: D, B5
[8416445]
(b)(4). The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If there is any further relevant info, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-04234 |
| MDR Report Key | 1495222 |
| Report Source | 05,07 |
| Date Received | 2009-09-04 |
| Date of Report | 2009-08-07 |
| Date of Event | 2009-08-07 |
| Date Mfgr Received | 2009-08-07 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2009-12-01 |
| 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 | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUESCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLEX AIRWAY STENT |
| Product Code | NYT |
| Date Received | 2009-09-04 |
| Model Number | M00570320 |
| Catalog Number | 7032 |
| Lot Number | 0000007301 |
| ID Number | NA |
| Device Expiration Date | 2012-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-04 |