MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-05-16 for EDWARDS PERICARDIAL PATCH 4700 manufactured by Edwards Lifesciences.
[1488781]
It was reported that the patient has expired after an implant duration of approximately zero days. On 04/22/2010, through follow-up with the health-care provider, it was learned that the patient expired due to cardiomyopathy and shock lung. Per the operative report of (b) (6) 2010: when this was completed, we took the crossclamp off and there was diffuse bleeding everywhere. We could not control the bleeding. We gave massive products of blood, fresh frozen plasma, platelets, cryoprecipitate and even novo-7. In addition to assist with the cardiac function, i inserted an intraaortic balloon pump through the right common femoral artery. The attempt was made to come off bypass, but the cardiac function was not good and the patient had shock lung. He had marginal pulmonary reserve to begin with and with the complexity and duration of this procedure, which was extraordinarily difficult, we went ahead and tried to come off again after going back on the pump a number of times giving more products and then we finally tried to come off and did so but the cardiac function was marginal based on the fact that he has severe valvular or severe cardiomyopathy and certainly not the mitral valvular problem explaining has failure, and he also was in shock lung and his po2 was 50 out of 100%. It was quite clear there was really nothing left to offer the patient, as i saw no potential hope for reversibility of any of the tissues that he had. The patient was pronounced dead in the operating room. The coroner was notified and the situation was explained to the coroner and the body was released. The family was kept updated and was notified. I spoke to the family on 2 occasions. I explained that everything that could be done was done and that i think the primary problem was intrinsic to the heart muscle and to the lungs. As i had mentioned to the family, everything that could possibly be done was done and everything we according to plan, but the case turned out to be significantly more difficult. I recognized the complexity and difficulty of the case in terms of the dilated cardiomyopathy and we decided initially and before we started, not to use an internal mammary and not to attempt to remove the left atrial appendage because of the severe scarring over that part of the pericardium.
Patient Sequence No: 1, Text Type: D, B5
[1537180]
(b) (4) clinical study. It was reported that following a coronary artery stenting procedure the patient experienced angina. The lesion being treated is unknown. The physician implanted a taxus liberte stent of unknown size on an unknown date. In (b) (6) 2009, the patient developed angina. In the opinion of the physician the cause of the angina pectoris might be restenosis. However, the patient refused cag and coronary ct scan. Therefore, no action has been taken.
Patient Sequence No: 1, Text Type: D, B5
[8571219]
Device not returned. This event was determined to be reportable per edwards lifesciences procedures. The event was learned through implant patient registry. Through follow-up with the health-care provider (via fax), additional information and the operative report was received. The device history record (dhr) review was completed, and there was no nonconformance found related to this event.
Patient Sequence No: 1, Text Type: N, H10
[8579591]
(b) (4) = shock lung. The patient also had a device explanted (model #6625-esr-lp; (b) (4)), however, that event is being reported on a quarterly alternative summary report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2010-13374 |
| MDR Report Key | 1690770 |
| Report Source | 05,06 |
| Date Received | 2010-05-16 |
| Date of Report | 2010-04-15 |
| Date of Event | 2010-04-02 |
| Date Facility Aware | 2010-04-02 |
| Date Mfgr Received | 2010-04-22 |
| Device Manufacturer Date | 2009-04-16 |
| Date Added to Maude | 2010-06-15 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NEIL LANDRY |
| Manufacturer Street | ONE EDWARDS WAY MS HVC96 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS PERICARDIAL PATCH |
| Generic Name | PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 2010-05-16 |
| Model Number | 4700 |
| Lot Number | R-09C0650 |
| Device Expiration Date | 2013-03-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-05-16 |