MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-06-15 for POLYFLEX STENT SYSTEM M00514300 1430 manufactured by Rusch Gmbh Germany/teleflex.
[669683]
Note: the date of death and the date of the event are unknown. It was reported to boston scientific corporation in 2007, that after the placement of a polyflex stent system in a female, the patient died. A stent was placed for a 2cm post-irradiation fibrotic stricture which was planned to be removed six to eight weeks later by the physician. The patient "went home without difficulty". The patient was later "readmitted for an unspecified reason and went home again". In early of the month, the patient was admitted emergently into the icu "with hematemasis, melena, and hematochezia". "the patient never stabilized and died before endoscopy was performed. No autopsy was done. " patient cause of death is unknown.
Patient Sequence No: 1, Text Type: D, B5
[7970183]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. A device history review and complaint trend analysis are in progress; results will be provided in a follow-up medwatch report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000146-2007-00030 |
| MDR Report Key | 865527 |
| Report Source | 05,07 |
| Date Received | 2007-06-15 |
| Date of Report | 2007-05-21 |
| Date Mfgr Received | 2007-05-21 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2007-09-18 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | RUSCH GMBH GERMANY/TELEFLEX |
| Manufacturer Street | 2345 WAUKEGAN ROAD |
| Manufacturer City | BANNOCKBURN IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLEX STENT SYSTEM |
| Product Code | NYT |
| Date Received | 2007-06-15 |
| Model Number | M00514300 |
| Catalog Number | 1430 |
| Lot Number | 0000007091 |
| Device Expiration Date | 2012-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 887663 |
| Manufacturer | RUSCH GMBH GERMANY/TELEFLEX |
| Manufacturer Address | BANNOCKBURN IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-06-15 |