MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2009-11-06 for POLYFLEX AIRWAY STENT M00570130 7013 manufactured by Boston Scientific Corporation.
[15188764]
Note: this report is one of six complaints filed for this event. Refer to mfr report# 3005099803-2009-05259, 3005099803-2009-05260, 3005099803-2009-05261, 3005099803-2009-05263, and 3005099803-2009-05264 for the other associated device info. It was reported to boston scientific corp (bsc) on october 7, 2009 that 6 polyflex airway stents were used during 6 esophageal stenting procedures performed on a male. According to the complainant, the pt had suffered from esophageal atresia since birth. The pt had undergone frequent repeated esophageal dilatations in hopes of removing his feeding tube. The attending physician was researching other options. She consulted with another physician regarding his temporary stenting technique. The physician was made aware by bsc that this was an off-indication technique. After thoroughly researching the use of stents, consulting with her team of surgeons, and receiving the consent of the pt's family, the physician decided to proceed with the treatment. Beginning in 2009, a series of 6 polyflex airway stents were placed consecutively in the pt's esophagus. Each of the first five stents were placed, left in place for approximately 2 weeks, and then removed without issue. The treatment was successful with the pt able to progress to the oral intake of food. The physician stated that the first five stents were unrelated to the event. The final stent was placed the following month. The following month, the pt was admitted to the hosp emergency room with esophageal bleeding. It was discovered that the pt had a congenital malformation of blood vessels which had ruptured due to pressure of the stent. The stent was removed without issue and the bleeding was stopped. A few days later, the pt expired. According to the physician, the cause of death was the congenital malformation of blood vessels that ruptured due to pressure of the final stent. This condition was unk at the time of placement and was only discovered when the pt presented with esophageal bleeding. An autopsy was performed. Bsc requested autopsy results and was informed that results would not be released. Although the physician stated that the first five stents placed were unrelated to the event, without the definitive cause of death from the autopsy results, bsc has decided to conservatively file medwatch reports on all six stent complaints associated with this event. Bsc will continue to pursue further clarification of this event. If add'l info is obtained, a supplemental mdr will be submitted to the fda. This report is for the fourth stent placed.
Patient Sequence No: 1, Text Type: D, B5
[15726848]
Exact implant & explant dates are unk. The complainant indicated that the device will not be returned for eval; therefore, a failure analysis of the complaint device could not be completed. If any further relevant info is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-05262 |
| MDR Report Key | 1525043 |
| Report Source | 00,01,05,06 |
| Date Received | 2009-11-06 |
| Date of Report | 2009-10-07 |
| Date of Event | 2009-08-28 |
| Date Mfgr Received | 2009-10-07 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2009-11-12 |
| 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 | 3 |
| 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, DE 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 | 2009-11-06 |
| Model Number | M00570130 |
| Catalog Number | 7013 |
| Lot Number | 0000009201 |
| Device Expiration Date | 2014-04-30 |
| 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 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2009-11-06 |