MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-10 for VALVE IN CARTRIDGE, 7MM HUS-V7 manufactured by Spiration.
[57464802]
Patient has history of severe upper lobe emphysema and secondary spontaneous right-sided pneumothoraces. On (b)(6) 2015 the patient was admitted with a right-sided pneumothorax. After 2 weeks air leak was still present; two valves were placed on (b)(6) 2015. The patient wanted the valves to remain in because of risk of recurring pneumothorax. The physician evaluated the patient several times over the next several months. On (b)(6) 2016, the physician did a surveillance bronchoscopy to assess the valves and noted that one of the valves was covered in granulation tissue. The physician recommended valve removal to avoid potential airway complications such as erosion or fistula. After debridement, the valve was removed in the standard fashion and without difficulty. The second valve was also removed without difficulty. Upon further inspection of the removed valve form the tracheal bronchus (where granulation occurred), it was noted that two of the five anchors were missing. The missing anchors were visible on ct scan in their original position in the tracheal bronchus. The current plan is for the patient to complete a short course of prednisone and allow time for much of the granulation tissue to resolve and re-evaluation the airway in approximately 1 month. Physician indicated that the patient was asymptomatic and well. As noted, the valve has been returned and is currently being evaluated. Upon conclusion of the evaluation, spiration will submit a follow-up report to fda summarizing results and conclusions.
Patient Sequence No: 1, Text Type: N, H10
[57464803]
Dr. (b)(6) reported that after the two 7mm valves were removed from the patient, he noticed one of the valves only had 3 anchors on it.
Patient Sequence No: 1, Text Type: D, B5
[68240056]
Spiration has conducted an investigation of this event. Based on sem and eds imaging, metallurgical analysis, and sem/backscatter analysis, as well as review of relevant astm standards, spiration concluded that most likely fatigue failure led to the anchor breaks. The most likely cause of the fatigue failure is the location of inclusions (near the surface in a high strain area) in the nitinol frame combined with the mechanical forces experienced by the valve. It was also determined that the inclusions in the material were within astm (b)(4) guidelines. This failure mode is in the fmea and the occurrence rate is within the stated occurrence rate. Spiration also had two outside health care professionals review the event and they each concluded independently that anchor breakage, even if left in the patient, is not a serious adverse event. However, to fully inform health care professionals and patients spiration is adding "valve fracture" to its "potential adverse effect" list in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004450998-2016-00001 |
| MDR Report Key | 6015000 |
| Date Received | 2016-10-10 |
| Date of Report | 2017-02-17 |
| Date of Event | 2016-09-13 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2016-10-10 |
| 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 | 3 |
| Manufacturer Contact | CYNDY ADAMS |
| Manufacturer Street | 6675 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 425636-545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALVE IN CARTRIDGE, 7MM |
| Generic Name | ONE WAY AIR LEAK VALVE |
| Product Code | OAZ |
| Date Received | 2016-10-10 |
| Returned To Mfg | 2016-09-23 |
| Model Number | HUS-V7 |
| Lot Number | W00600-01 |
| ID Number | 00896506002101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION |
| Manufacturer Address | 6675 185TH AVENUE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-10 |