MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-16 for RUSCH POLYFLEX STENT KIT M00570280 7028 manufactured by Boston Scientific - Marlborough.
[1320593]
It was reported to boston scientific corporation that a polyflex airway stent was used during a bronchoscopy with stent placement procedure performed on (b) (6) 2009 ((b) (6) male; weight unknown). According to the complainant, a polyflex stent was placed on (b) (6) 2009 to treat tracheomalacia. A checkup has been performed every 3 months since the procedure to re-examine the stent. On (b) (6) 2010, the patient reported difficulty breathing. The physician discovered that the distal portion of the stent had collapsed. In addition, a small fracture or hole was seen in the stent wall. The stent was removed later that day. The patient was reported to be doing well and was discharged the next day. Another stent has not yet been implanted. Before implanting another stent the physician wants to allow the granulation tissue time to heal and the bacterial colonization to decrease. The physician plans to perform a bronchoscopy at a later date to assess the patient? S airways. The physician has discussed further stenting options with the patient. The physician is considering implanting either a dynamic y stent or an alveolus/aero hybrid stent. The patient? S tracheal diameter is large (about 20-22mm) and the patient is obese making him a somewhat difficult candidate for rigid procedures.
Patient Sequence No: 1, Text Type: D, B5
[1546457]
It was reported to boston scientific corporation that a polyflex airway stent was used during a bronchoscopy with stent placement procedure performed on (b)(6) 2009 ((b)(6) male; weight unknown). According to the complainant, a polyflex stent was placed on (b)(6) 2009 to treat tracheomalacia. A checkup has been performed every 3 months since the procedure to re-examine the stent. On (b)(6) 2010, the patient reported difficulty breathing. The physician discovered that the distal portion of the stent had collapsed. In addition, a small fracture or hole was seen in the stent wall. The stent was removed later that day. The patient was reported to be doing well and was discharged the next day. Another stent has not yet been implanted. Before implanting another stent the physician wants to allow the granulation tissue time to heal and the bacterial colonization to decrease. The physician plans to perform a bronchoscopy at a later date to assess the patient's airways. The physician has discussed further stenting options with the patient. The physician is considering implanting either a dynamic y stent or an alveolus/aero hybrid stent. The patient's tracheal diameter is large (about 20-22mm) and the patient is obese making him a somewhat difficult candidate for rigid procedures.
Patient Sequence No: 1, Text Type: D, B5
[8449953]
(b) (4) therapy/non-surgical intervention, additional, patient complications. Stent damage. The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[8566750]
Only the stent body was returned for analysis. A visual evaluation of the returned device was conducted, and revealed that the stent had a strong yellow discoloration. The elastic material was not provided and the stent body was hard. The fibers at the distal end of the stent were destroyed, and a hole was observed in the inner part of the stent, most likely due to excessive force used during removal. Based on the condition of the returned device, the root cause can not be definitively determined; however the damage to the stent may be due to anatomical factors. A review of the device history record (dhr) was performed; no anomalies were noted that could be related to this complaint. A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2010-00687 |
| MDR Report Key | 1600023 |
| Report Source | 07 |
| Date Received | 2010-02-16 |
| Date of Report | 2010-01-19 |
| Date of Event | 2010-01-19 |
| Date Mfgr Received | 2010-04-27 |
| Date Added to Maude | 2010-05-12 |
| 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 | 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 | 2010-02-16 |
| Model Number | M00570280 |
| Catalog Number | 7028 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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. Required No Informationntervention | 2010-02-16 |