MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-16 for PROVOX VEGA 8283 manufactured by Atos Medical Ab.
[142204320]
On (b)(6) 2019: meeting with slp and physician: starting (b)(6), patient was unable to tolerate / swallow food and liquids. The patient presented on (b)(6) with severe joint pain, posterior neck pain, shoulder pain and bilateral arm pain. Pain had been progressive. Sleep was also impaired. Patient experienced a 15 lb weight loss over a 1 month period. Patient was made npo at that time. Stenosis of the cervical esophagus was not identified, but it was noted that there may be a narrow ap dimension as patient with voicing issues if voice prosthesis is slightly loose. Also noted that when tube was removed, extra length of prosthesis was pushed forward into trachea, suggesting posterior wall was abutting esophageal end of voice prosthesis. The vp was embedded within the posterior esophageal wall, into the pre-vertebral space; the vp was not embedded into the bone, however the bone was physically soft. There was a positive diagnosis for osteomyelitis; the patient was also septic. The patient had a deep space neck infection (necrosis). It is felt that the vp eroding into the pre-vertebral space was the etiology of the infection. The vp was removed through an anterior approach through the left side of the neck through to the pre-vertebral space. The area was then washed out and the vp was removed. A drain was placed. A stent was placed within the pharyngo-esophageal space. The patient was started on antibiotics. Of note, esophageal tissue was not observed to have signs consistent with reflux. Aside from fact that puncture is low and needs stoma dilation using a 10/55 larytube for vp changes, the last few valve changes have been without complication. Puncture is also dilated prior to vp changes. Capsule insertion method is used with all changes. Did the patient approach the physicians before with leakage? Only when there was central leakage/when needed a vp change. The patient received radiation post-operatively to the hypopharynx. At this time the patient remains npo with peg-tube feedings. The stent remained in place until (b)(6), when it was removed. The patient uses a trutone el for communication and continues with slp for therapy to maximize communication skill set. Theory at meeting: given the patient's baseline aggressive speaking behaviors, known esophageal narrowing, location of the puncture site and the pressure used to achieve voicing, eventually the vp migrated posteriorly into the esophageal space and then into the posterior esophageal wall. Of note, the site where the patient was punctured was low in the stoma because the cancer was in the hypopharynx. Current manufacturer conclusion: a very unfortunate coincidence of different factors use of vp and larytube in combination with forceful stoma occlusion/"aggressive speaking behavior", possible incorrect length of the voice prosthesis (vp), narrow esophagus, irradiated tissue, delayed diagnosis (no adequate medical action in response to previous complaints such as difficulty voicing in the months prior to the event). Vp is not the cause, but is a contributing factor: without the vp this would not have happened. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142204321]
This is a summary of the information that was received from the reporting slp: patient chart notes note difficulty with the voicing in the months prior to this event, which was previously always resolved by brushing. Patient has a narrow esophagus, and reported need to force his voice. He also wears a trach due to stoma stenosis. Patient presented with changes in voicing ability which progressed to fevers and ultimately was found to have back of tep eroded into a vertebral body. It was embedded in a fistula in posterior wall of esophagus. Doctor removed prosthesis and placed esophageal stent to protect the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2019-00002 |
| MDR Report Key | 8517265 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-16 |
| Date of Report | 2019-03-19 |
| Date Facility Aware | 2019-03-19 |
| Report Date | 2019-03-19 |
| Date Reported to Mfgr | 2019-03-19 |
| Date Mfgr Received | 2019-03-19 |
| Date Added to Maude | 2019-04-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELIN ALGOTSSON |
| Manufacturer Street | KRAFTGATAN 8, P.O. BOX 183 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8, P.O. BOX 183 |
| 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 | 2019-04-16 |
| Model Number | 8283 |
| Lot Number | UNKNOWN |
| 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, P.O. BOX 183 H?RBY, 242 22, S SW 242 22, SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Deathisabilit | 2019-04-16 |