MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-26 for PROVOX VEGA manufactured by Atos Medical Ab.
[90320640]
Provox vega. Investigation: investigation of product was not possible since no product was returned. The complaint concerns a leakage around the valve, and there is no information about how long the prosthesis has been used. There is no reason to believe that the leakage around prosthesis is due to product fault. Discussion: a leakage around the puncture is most often related to the quality of the puncture. A weak or miss shaped puncture gives less retention force towards the voice prosthesis t-flange and e-flange, this means that a leakage around may occur. If this is the case, a use vega xtraseal or xtraflange might help. It is also possible to use vega xtraseal together with an xtraflange, which might give a better fixation of the device. The ifu describes what to look for if there could be a problem with the puncture a leakage around may also occur if the tracheal flange and/or the esophagus flange are heavily affected by biofilm formation, or if the prosthesis has been damaged during insertion by wrong handling e. G. By use of sharp instrument. An external physician was consulted: it is almost impossible with this information to give a good explanation of the events. The malnutrition / cachexia can have many causes, and pneumonia can easily complicate a case with cachexia, also without aspiration. Periprosthetic leakage can be related to cachexia as well. In general, patients with a laryngectomy do not have a higher risk of pneumonia. In case of leakage, mild aspiration rarely leads to pneumonia. Only chronic aspiration or non-treated aspiration is dangerous. So that is why the surgeon performed the closure. Probably it failed because the patient was cachectic, but many other reasons are possible for failed surgery. If the leakage cannot be stopped by conservative measures, in general a cuffed cannula is needed until the leakage is stopped. I have no information on that. A salvage surgery can also be performed. So, based on the information you give, it is difficult to really explain al events and their relationship conclusion/action: no reason to believe any product failure, no reason for corrective or preventive actions.
Patient Sequence No: 1, Text Type: N, H10
[90320641]
This is the information that was received from the atos medical local representative: the patient died of pneumonia on (b)(6). He had been in the hospital since (b)(6). Dr. Said that the patient seemed to lose quite a bit of weight lately. Leakage around the prosthesis started to occur and hadn't improved. The patient became pneumonia due to voice prosthesis. Additional information was received after our sales rep visited the hospital. Our sales rep revisited the hospital to ask the patients the following; the doctor seemed to have second thought for now that the provox vp was not directly-related to the outcome. - do you know if they did anything to stop the leakage around? The doctor tried to stop the leakage through surgery operation to three-layer-close the te puncture site with pectoral major musculocutaneous flap after extracting the vp by referring to the medicine papers below. Once the closure seemed succeeded but the flap was detached to leak again. - were there other comorbidities as a possible cause for the pneumonia? The patient was suffering from spondylitis. He could not walk without walking aid. He seemed so thin that have poor nutrition. - how long was the vp in situ, when did the leaking start (time between start leakage, diagnose leakage, diagnose pneumonia), who and how was it diagnosed? When the patient was admitted, the leakage around had already been occurred. - "patient seemed to lose quite a bit of weight lately": what is lately, what is the relation with the pneumonia, or other diseases? See above. The doctor presumed it was because of his malnutrition and inconvenience from spondylitis. - leakage around can be caused by a too long vp (pistoning) solved by replacement with a shorter device the doctor did not think so. - other (underlying) causes for leakage around are not vp-related, but tep tract-related, such as: o reflux, o recurrence, o diabetes, x malnutrition, o rt/crt, o thyroid dysfunction, o etc. - did they perform assessments to diagnose the leakage and/or the enlargement of the fistula, and was there an adequate treatment? See the first answer. The doctor diagnosed the size of the fistula was too enlarged to cover with xtraflange or xtraseal and operated to close the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2017-00012 |
| MDR Report Key | 6979357 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-09-18 |
| Date Mfgr Received | 2017-10-13 |
| Date Added to Maude | 2017-10-26 |
| 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. KAROLINA NILSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX VEGA |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-10-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Death | 2017-10-26 |