MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2011-02-17 for IBV VALVE SYSTEM REF-HU-VS-7 manufactured by Spiration, Inc..
[19618775]
Spiration reviewed device labeling (instructions for use and patient brochure) and confirmed that: the adverse event (pneumothorax) was listed as potential/anticipated, and the use of the ibv valves was off-label. Method: reviewed the (b)(4) report sent by the physician to his irb on (b)(6) 2011. Based on the review of the (b)(4) report, the ibv valve is not suspected to have failed or malfunctioned. This report is being submitted as an mdr with an abundance of caution. If additional significant info is provided, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[19844192]
Pt (b)(6) underwent a bronchoscopy procedure performed by dr. (b)(6) on (b)(6) 2011 for ibv valve placement (off-label use) to treat the giant bullae in the left upper lobe. A post-procedure chest x-ray on (b)(6) 2011 could not rule out a pneumothorax; however, the pt was hemodynamically stable. On (b)(6) 2011, a repeat chest x-ray was performed which also could not confirm or rule out pneumothorax. A ct scan was then requested and a pneumothorax was visible with left lower lobe collapse and mediastinal shift to the right. The pt became tachycardic, hypotensive, and was in respiratory distress. A chest tube was placed and connected to wall suction with clinical and radiographical improvement. The (b)(4) report to the irb dated (b)(6) 2011 stated that: the event was probably related to the device based on the timeline of the event within 24 hours of the procedure, the event did not increase the likely risk or decrease the likely benefit to pts, and this risk is expected as it is listed in the pt brochure given to pt during the consent process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2011-00001 |
| MDR Report Key | 2001117 |
| Report Source | 04,05,06 |
| Date Received | 2011-02-17 |
| Date of Report | 2011-02-17 |
| Date of Event | 2011-02-09 |
| Date Mfgr Received | 2011-02-09 |
| Device Manufacturer Date | 2010-06-17 |
| Date Added to Maude | 2011-04-19 |
| 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 AVE. 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 | 2011-02-17 |
| Catalog Number | REF-HU-VS-7 |
| Lot Number | W04036-01 |
| 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. Hospitalization; 2. Life Threatening | 2011-02-17 |