MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-06-05 for POLYFLEX AIRWAY STENT M00570160 7016 manufactured by Boston Scientific Corporation.
[1196616]
Note: date of event is unknown. On 05/07/2009, a boston scientific employee became aware of an article, "mediastinal migration of self-expanding bronchial stents in the management of malignant bronchoesophageal fistula" s. Alazemi mc et al. Chest 2009; 135; 1353-1355, doi 10. 1378/chest, 2006. A female with stage iv adenocarcinoma of the breast was experiencing increasing dyspnea and a cough which was aggravated by eating and drinking. The patient underwent a ct scan of the chest which showed evidence of extensive mediastinal tumor invasion with a fistula between the mid-portion of the esophagus and the proximal left main bronchus. She underwent stent placement of a covered polyflex airway stent. Two weeks post stent placement, the patient was admitted to the hospital with a worsening cough. Shortly afterward, she presented with chest pain, worsening cough and breathlessness. An esophagoscopy was performed, and another polyflex airway stent was placed in an attempt to seat the residual fistula. In addition, a percutaneous gastrostomy tube was placed for nutritional support and prevention of further aspiration. Despite treatment the patient continued to have a cough that became persistent and associated with chest pain. A ct scan of the chest revealed the polyflex airway stent protruding through the medial wall of the right main bronchus (rmb) completely obstructing the bronchus intermedius (bi). The airway stent was removed easily using rigid forceps. At this point, the carinal anatomy was severely distorted, with a bilateral bronchial wall perforation and a floppy middle portion. An attempt was therefore made to reconstruct the carina endoscopically with various airway prostheses. The procedure was tolerated well by the patient, who had significant clinical improvement of her dyspnea and chest pain. In addition, a repeat ct scan of the chest confirmed the restoration of airway patency on the right side. She was discharged from the hospital to home shortly after completing a course of antibiotics with nutritional support provided exclusively via the gastrostomy tube. At follow-up 2 months later, the patient remained stable at home with no further hospitalization.
Patient Sequence No: 1, Text Type: D, B5
[8463848]
The complainant was unable to provide the suspect device lot number; therefore, the device expiration and manufacture dates are unknown. 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 information, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-02731 |
| MDR Report Key | 1400114 |
| Report Source | 05,07 |
| Date Received | 2009-06-05 |
| Date of Report | 2009-05-07 |
| Date Mfgr Received | 2009-05-07 |
| Date Added to Maude | 2009-06-15 |
| 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 RUSCH GMBH |
| Manufacturer Street | WILLY RUSCH-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 | 2009-06-05 |
| Model Number | M00570160 |
| Catalog Number | 7016 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 1. Required No Informationntervention | 2009-06-05 |