MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-06-09 for PROVOX VEGA XTRASEAL 22.5FR 12.5MM 7786 manufactured by Atos Medical Ab.
[77424005]
Investigation: this is an initial report. Investigation will be performed but it seems that the xtraseal that was placed was too long, causing food to drag it down. So most likely ingested (and come out the natural way). An xtraseal is typically placed in a puncture that is a bit enlarged so it could more easily dislodge, and it is designed to dislodged more easily to the esophagus. Device is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[77424006]
This is the information that was received from the atos medical local representative: patient has now strong concerns when to try to cough strongly because of possible aspiration/ingestion. So he would like to know the possible reason and countermeasure to them. And he expect if any foods might catch the esophageal side of the extruded vp. Patient's history to event: - (b)(6) 2017; replaced vega 22. 5fr 8 mm into new one (8 mm) because of leakage. - (b)(6); replaced into xtraseal 10 mm because of leakage. - (b)(6); replaced into xtraseal 12. 5 mm because of leakage. A nurse reminded that the new vp seemed so long that it was extruded toward esophageal side. The doctor reminded that the status of shunt hole of the patient seemed good. - (b)(6); during dinner, the patient got stuck in his throat and (we are not sure exactly) the vp was aspirated/ingested accidentally. At that day, he went to the hospital to ask to indwell another new vp of xs 12. 5 mm. As of today, the doctor has not confirmed where the missing vp is, but there are no symptoms related to aspiration on the patient. - (b)(6); at lunch, he choked over when he drunk. The vp was aspirated/ingested again. In that afternoon, he went to the hospital. Then, placed vega 10 mm. At the same day, our reps received this information. The patient would like to know the reason of aspiration/ingestion and how to keep the indwelled vp longer and stable.
Patient Sequence No: 1, Text Type: D, B5
[116938973]
Investigation: the product was not returned in this complaint, an investigation of the product is therefore not possible. Discussion: the provox vega voice prosthesis is designed with a sturdier esophageal flange than tracheal flange that will minimize the risk of aspiration thus if the vp comes loose it will most likely end up in esophagus and out the "natural way". In a healthy round te puncture the flanges give a stable fit that resist coughing/choking thus should not dislodge. One could speculate, if the te puncture is asymmetric the flanges has lost part of its support thus have less resistance to coughing and can come loose. One could also consider using provox xtraflange to reduce periprosthetic leakage. It should be unlikely that food catch the esophageal side of the extruded vp and dislodge the vp. However with excessive long vp the risk increases. It is important to try out the correct size of prosthesis to the patient. Device is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[116938974]
This is the information that was received from the atos medical local representative: patient has now strong concerns when to try to cough strongly because of possible aspiration/ingestion. So he would like to know the possible reason and countermeasure to them. And he expect if any foods might catch the esophageal side of the extruded vp. Patient's history to event: on (b)(6) 2017; replaced vega 22. 5fr 8mm into new one (8mm) because of leakage. (b)(6); replaced into xtraseal 10mm because of leakage. (b)(6); replaced into xtraseal 12. 5mm because of leakage. A nurse reminded that the new vp seemed so long that it was extruded toward esophageal side. The doctor reminded that the status of shunt hole of the patient seemed good. (b)(6); during dinner, the patient got stuck in his throat and (we are not sure exactly) the vp was aspirated/ingested accidentally. At that day, he went to the hospital to ask to indwell another new vp of xs 12. 5 mm. As of today, the doctor has not confirmed where the missing vp is, but there are no symptoms related to aspiration on the patient. (b)(6); at lunch, he choked over when he drunk. The vp was aspirated/ingested again. In that afternoon, he went to the hospital. Then, placed vega 10mm. At the same day, our reps received this information. The patient would like to know the reason of aspiration/ingestion and how to keep the indwelled vp longer and stable. Additional information in this follow up report, 2017-06-16: the doctor did a chest and an abdominal ct on the patient this week and found no vp remaining in his body. The doctor regarded it as being already gone-out of the body and patient seemed to be relieved. This case was closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2017-00007 |
| MDR Report Key | 6629047 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-06-09 |
| Date of Report | 2017-05-13 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-06-16 |
| Device Manufacturer Date | 2016-08-23 |
| Date Added to Maude | 2017-06-09 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX VEGA XTRASEAL 22.5FR 12.5MM |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-06-09 |
| Catalog Number | 7786 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 0 YR |
| 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 | 2017-06-09 |