MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-09 for PROVOX VEGA 8132-02 manufactured by Atos Medical Ab.
[46871521]
Investigation of the returned device: the device is returned incomplete; the whole esophagus flange of the prosthesis is torn away. The blue ring inside the valve is deformed, but still safely attached to the waist of the prosthesis. One part of the fraction surface is jagged and one part is smooth. The valve flap and the jagged part of the fraction surface is covered in biofilm indicating that the fracture has been present during use. The lack of biofilm on the smooth part of the rupture surface indicates that the esophagus flange was torn completely loose during removal. Conclusion: no indication of product fault is found. Most likely, the wrong method was used during insertion or during reloading. This resulted in abnormal stress to material and components which caused the rupture. The conclusion is based on the severe damages of the blue ring and how the biofilm has grown on fraction surfaces. The clinician should be instructed to read the ifu to secure a proper handling when inserting the prosthesis. The clinician may also need additional training.
Patient Sequence No: 1, Text Type: N, H10
[46871522]
This is the information that has been received from atos medical local representative in (b)(6): a clinician found that there was no the esophagus flange on the prosthesis when it was removed. The clinician and patient don't know where the esophagus flange is. It probably fell into the esophagus since the patient status is unaffected. The prosthesis has been used for 14 weeks. A granulation tissue around the te-puncture in the esophageal side has formed. The patient could not speak just before the replacement. After replacement it was possible but still hard to speak. The lot number is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00007 |
| MDR Report Key | 5708542 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-09 |
| Date of Report | 2016-06-09 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-05-19 |
| Date Added to Maude | 2016-06-09 |
| 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 | MS. ELIN ALGOTSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| Manufacturer Phone | 641519800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-24222 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX VEGA |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-06-09 |
| Returned To Mfg | 2016-05-23 |
| Catalog Number | 8132-02 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8 HORBY, SE-24222 SW SE-24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-09 |