MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-19 for AEROFORM? TISSUE EXPANDER SYSTEM, V2.5 LP120-650 FG-0009-02 manufactured by Airxpanders, Inc..
[75603018]
The left tissue expander serial# (b)(4) was evaluated, and the reported issue was confirmed. Three additional drainage holes were found in the outer shell during inspection; however, this expander modification is not believed to have contributed to the reported deflation. The inner bag which contains the carbon dioxide gas does not show implant rupture. Further evaluation indicates that the expander material shows distress points and creases. No evidence of leakage was observed during immersion testing. Per the physician's report and evaluation of the dose log graphs, the dosage controller functioned as intended. The physician used the optional physician fill mode (pfm), which allows the physician to add additional volume fill. The dosage controller locked out when it reached the physician fill limit, as required. The primary root cause of the reported volume loss was due to interlayer delamination and creases of the implant material layers, leading to loss of volume. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75603019]
A patient underwent immediate bilateral reconstruction with placement of tissue expanders on (b)(6) 2016. Expansion was reported to have started without any complications. On (b)(6) 2017, the surgeon reported the left tissue expander was deflating, despite the surgeon engaging the physician fill mode to allow for additional volume fill to compensate for volume loss. On (b)(6) 2017, the surgeon elected to remove the left tissue expander and replaced it with another aeroform? Tissue expander. No injuries are reported for this patient following the removal and replacement with another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009130440-2017-00001 |
| MDR Report Key | 6580229 |
| Date Received | 2017-05-19 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-05-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSE VASQUEZ |
| Manufacturer Street | 1047 ELWELL COURT |
| Manufacturer City | PALO ALTO CA 94303 |
| Manufacturer Country | US |
| Manufacturer Postal | 94303 |
| Manufacturer Phone | 6502828140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AEROFORM? TISSUE EXPANDER SYSTEM, V2.5 |
| Generic Name | CARBON DIOXIDE GAS CONTROLLED TISSUE EXPANDER |
| Product Code | LCJ |
| Date Received | 2017-05-19 |
| Returned To Mfg | 2017-05-01 |
| Model Number | LP120-650 |
| Catalog Number | FG-0009-02 |
| Lot Number | F03030 |
| Device Expiration Date | 2017-09-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AIRXPANDERS, INC. |
| Manufacturer Address | 1047 ELWELL COURT PALO ALTO CA 94303 US 94303 |
| Brand Name | AEROFORM? TISSUE EXPANDER SYSTEM, V2.5 |
| Generic Name | CARBON DIOXIDE GAS CONTROLLED TISSUE EXPANDER |
| Product Code | PQN |
| Date Received | 2017-05-19 |
| Returned To Mfg | 2017-05-01 |
| Model Number | LP120-650 |
| Catalog Number | FG-0009-02 |
| Lot Number | F03030 |
| Device Expiration Date | 2017-09-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRXPANDERS, INC. |
| Manufacturer Address | 1047 ELWELL COURT PALO ALTO CA 94303 US 94303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-19 |