MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2012-05-14 for IBV VALVE SYSTEM REF-HU-VS-7 manufactured by Spiration, Inc..
[2729188]
Elderly pt had a bronchoscopy procedure done by dr. (b)(6), (b)(6) 2012, for ibv valve placement to treat post-op air leak after lung cancer lobe resection. In 1 week, air leak had sealed and chest tube was removed. Six weeks post-op, pt was hospitalized for copd exacerbation. Dr. (b)(6) discussed valve removal with the pt's primary physician, who said that although the pt was still hospitalized, he was not likely to improve. Dr. (b)(6) decided to proceed with valve removal. At bronchoscopy, pus was noted, presumably from a bronchial infection; pus suctioned to clear the airways. Valve removal was without difficulty, but there was mild bleeding; suctioned clear and self-limited. Pt had subsequent tachypnea in recovery and was moved to icu on bipap. Later that day pt required intubation for ventilatory support and bronchoscopy. Bronchoscopy revealed clot occluding rt mainstem; clot removed and further bleeding noted; coagulation test ok. Pt suctioned for large amount of blood from removal site. Pt never did well post original lung cancer resection. Family requested withdrawal of support; pt died.
Patient Sequence No: 1, Text Type: D, B5
[9925567]
Spiration reviewed device labeling (instructions for use and pt brochure) and confirmed that the adverse events which were reported are listed as potential/anticipated. Based on the review of the mfg dmr and dhr, the ibv valve is not suspected to have failed or malfunctioned. Method: reviewed the sae report sent by the physician to his irb on (b)(6) 2012. The sae report to the irb dated (b)(6) 2012 stated that the initial sae (bleeding) was definitely related to the valve removal procedure. This report is being submitted as an mdr with an abundance of caution. If add'l significant info is provided, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004450998-2012-00001 |
| MDR Report Key | 2622888 |
| Report Source | 04,05,06,07 |
| Date Received | 2012-05-14 |
| Date of Report | 2012-05-14 |
| Date of Event | 2012-04-25 |
| Date Mfgr Received | 2012-05-09 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-06-21 |
| 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 | LINDA RISMONDO |
| Manufacturer Street | 6675 185TH AVENUE, NE. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254971700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IBV VALVE SYSTEM |
| Generic Name | ONE-WAY AIR LEAK VALVE |
| Product Code | OAZ |
| Date Received | 2012-05-14 |
| Catalog Number | REF-HU-VS-7 |
| Lot Number | W04288-01 |
| Device Expiration Date | 2012-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening | 2012-05-14 |