MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-02-22 for HEMASHIELD manufactured by Maquet Cardiovascular Llc.
[136883167]
The event occurred in (b)(6) 2009, however the exact event date is unknown. It was arbitrarily set to (b)(6) 2009. Device is not accessible since the patient died 10 years ago. No investigation could be performed to date since there is no graft identification available. The investigation is still ongoing. A follow-up report will be sent upon completion of the investigation. Please note the editorial commentary at the end of the article: "this is an interesting association, but two things should be borne in mind by our readership. The first is the anatomic proximity itself. Although the aortic root is contiguous with the left ventricular outflow tract and with the aorto-mitral fibrous curtain between the aortic valve and the mitral valve, it is not contiguous with the right atrium. The second issue is the difference between temporal association and causal association. There is a clear temporal association between carrying a cigarette lighter and the development of lung cancer, but the lighter does not cause lung cancer: rather, those people who carry lighters are much more likely to be cigarette smokers. The authors make no outright claims about causation in their carefully written article, and it is important that something as common in cardiovascular surgery as the implantation of dacron into the body not instill fear of consequent sarcoma".
Patient Sequence No: 1, Text Type: N, H10
[136883168]
This is a published case report of primary cardiac angiosarcoma that developed in a woman who had undergone an aortic dissection repair with a dacron graft prosthesis 9 years earlier. In (b)(6) 2009, a (b)(6) woman presented with worsening shortness of breath and upper-back pain of 1 month's duration. She had also experienced fatigue and a 15-lb weight loss over the preceding month. She denied chest pain, orthopnea, or lower-extremity swelling. She was afebrile, without chills or night sweats. The diagnosis was of a primary cardiac angiosarcoma with extensive multiorgan metastases and consequent pathologic thoracic vertebral fracture. Her chronic aortic dissections and the aortic prosthetic graft were stable. She was started on paclitaxel chemotherapy. In addition, she underwent 6 sessions of radiation therapy to her thoracic spine. Her clinical condition remained stable for 2 weeks but deteriorated thereafter, characterized by worsening fatigue and back pain. She chose to discontinue chemo- and radiotherapy in favor of hospice care. She died 1 week later. Dacron prostheses have rarely been associated with neoplasia, and no causal relationship has been established. The reference of the article is the following: almeida nj, et al. Primary cardiac angiosarcoma in a patient with a dacron aortic prosthesis. Tex heart inst j 2011;38(1):61-5. The web address location for the complete case report is the following: https://www. Ncbi. Nlm. Nih. Gov/pmc/articles/pmc3060733/pdf/20110200s00012p61. Pdf.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2019-00011 |
| MDR Report Key | 8362273 |
| Report Source | LITERATURE |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date of Event | 2009-02-01 |
| Date Mfgr Received | 2019-01-23 |
| Date Added to Maude | 2019-02-22 |
| 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 | MRS. LAURE FRAYSSE |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal | 13705 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMASHIELD |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2019-02-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2019-02-22 |