MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-06-04 for PHOTOFIX PATCH UNKNOWN manufactured by Cryolife, Inc..
[109982819]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[109982820]
According to an article: a (b)(6) male "underwent re-operation for severe regurgitation of the valve consisting of patch augmentation of the mural leaflet with bovine pericardium stabilized using dye-mediated photo-oxidation fixation process. After surgery he resumed normal activity including strenuous weightlifting and was well until, five months later, he experienced sudden onset of dyspnea and exercise intolerance. Echocardiography showed severe regurgitation emanating from the region of the mural leaflet. Three-dimensional imaging depicted a disruption in the mural leaflet at the annulus. Intraoperative inspection revealed that the running suture had pulled through the patch at multiple sites along the annulus. To analyze the patch dehiscence, we [research specialist associated with the article] determined the maximum expected leaflet load in a normal mitral valve at typical peak systolic pressures based on published studies. During weightlifting, systolic pressures as high as 480 mmhg have been measured in normotensive subjects. Leaflet stress increases in proportion to pressure, so we scaled our estimate to reflect this elevated systolic pressure, yielding an estimate of the maximum expected load on the leaflet near the annulus of 1. 6 n/mm. We then measured suture retention strength, which, combined with an estimated suture spacing of 2 mm, results in a suture line strength of 1. 6 n/mm, indicating that the maximum expected load on the repaired valve during weightlifting might indeed reach the level at which the suture line is predicted to fail. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00019 |
| MDR Report Key | 7566225 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-06-04 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-04-24 |
| Date Facility Aware | 2018-05-07 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-06-04 |
| 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 | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 6782904624 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOTOFIX PATCH |
| Generic Name | INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED |
| Product Code | PSQ |
| Date Received | 2018-06-04 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-06-04 |