MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-02-12 for PHOENIX HANDPIECE HP-PHX manufactured by Cryolife, Inc..
[5443116]
The distributor received a phone call on (b)(6) 2015 from (b)(6) stating that a phoenix handpiece was used for a surgery on (b)(6) 2015. It was reported that "a lot of bleeding from ventricle" occured during revascularization and "couldn't maintain hemostasis for 15 min. "
Patient Sequence No: 1, Text Type: D, B5
[12827324]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[38831718]
According to the initial report, a representative from the distributor reported "i just had call from (b)(6) hospital, today they are using phoenix handpieces, during first revascularisation had a lot of bleeding from ventricle and couldn't maintain hemostasis for 15 min. Asking if the optical fiber is different than it was previously because in the past they didn't have such problems. Is the fiber thicker in phoenix than it sologrip? Or maybe they are using wrong technique, what is your advice? " conversation with the surgeon on 02/20/2015 indicated the following: the surgeon is conducting a pilot study of 40 patients using the device to perform tmr along with injection of stem cells derived from adipose tissue. To date, the surgeon has used the device in three cases and has experienced bleeding in one of the cases. He was interested to know if the diameter of the fiber optic had changed since previous versions of the device. There is no record of any change to the outer diameter of the epoxy tip. I communicated this to the surgeon who then felt the likely cause of the bleeding was a friable left ventricle. The patient had 2 previous myocardial infarctions. A total of 6 channels were made in the left ventricle with 5-6ml of a stem cell mixture injected just after each channel was created. The case was a stand-alone procedure and was conducted off pump via a mini incision at the 5th intercostal space. The surgeon indicated he observed bleeding in the area around 4 of the 6 channels. The bleeding was controlled after 10-15 minutes using surgicel and the patient did not suffer any additional complications and has recovered. The surgeon commented that the needles could be approximately 1-2mm longer for maximum benefit during injection, but that the current design works fine. He has three additional cases planned in the next 6-8 weeks. After our discussion, he felt the likely cause of bleeding was not related to the device, but more related to the poor quality of the left ventricular tissue. A review of records for phoenix handpiece lot ta-04065 was performed. A manufacturer's review was not requested as a copy of the manufacturing records is maintained in house. The handpiece was not returned for a sample review. According to documentation, all approved handpieces were constructed appropriately, with approved components, and passed quality testing and final inspection. In addition to this, there were no non-conformances found during the incoming inspection of the lot at cryolife. A review was held based on available information. The phoenix handpiece is specifically designed to allow physician directed injections of biologic or pharmacologic agents to pre-determined areas of myocardium with reversible ischemia in conjunction with delivery of tmr therapy. The indications for use statement in the instructions for use (ifu) defines the medical conditions to be treated as follows: "transmyocardial revascularization with the cardiogenesis tmr system is indicated for treatment of stable patients with angina (canadian cardiovascular society class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization. " early experience with the phoenix handpiece demonstrates the device is safe and the efficacy of tmr and cell therapy should continue to be studied (patel 2007, reyes 2009, konstanty 2013). The addition of the fluid injection with the phoenix handpiece has not increased the occurrence of adverse events as the available clinical experience shows improvements in ccs angina class without any reported adverse events or operative mortality (patel 2007, reyes 2009, konstanty 2013). Additionally, all cardiogenesis handpieces have the same diameter fiber. There have been no reports of excessive bleeding or blood transfusions required due to blood loss from tmr among 275 patients who took part in the randomized sole therapy tmr clinical trials from 1996-1998 (tmr ifu). In addition, there have been no reports from the literature pertaining to excessive intra-operative bleeding following tmr with the phoenix handpiece. The ifu includes statements regarding precautions that should be taken in regards to anti-coagulant and anti-platelet therapies. It states that patients receiving less reversible anti-coagulant therapy (e. G. , plavix? ) should be changed to heparin at least 5 days prior to the procedure so that anti-coagulation can be more readily reversed. In addition, patients should be weaned from anti-platelet therapy (e. G. , plavix? ) for at least 5 days prior to undergoing the tmr procedure. The risk of tmr must be weighed against the potential benefits. The patient's pre-operative and intra-operative anti-coagulation status is unknown. No action required at this time. To date, this is the first report of intra-operative bleeding during tmr with the phoenix handpiece. In addition, the surgeon stated he felt the bleeding was not related to the device, but more related to the poor quality of the left ventricular tissue. According to the available information, a patient experienced bleeding following a tmr procedure using the phoenix handpiece. According to the surgeon, there was bleeding from 4 of the 6 channels for 10-15 minutes. The bleeding was controlled with surgicel and the patient experienced no further complications. Since the channel is transmural, bleeding is not unexpected. The extended time of bleeding could be related to anti-coagulation therapy or a friable (necrotic) myocardium. Furthermore, the surgeon felt that a friable myocardium was the most likely cause. Given these findings as well as statements from the surgeon, utilization of the cardiogenesis handpiece hp-phx in the tmr procedure was not the cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[38831719]
The distributor received a phone call on (b)(6) 2015 from (b)(6) stating that a phoenix handpiece was used for a surgery on (b)(6) 2015. It was reported that "a lot of bleeding from ventricle" occured during revascularization and "couldn't maintain hemostasis for 15 min. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00023 |
| MDR Report Key | 4510763 |
| Report Source | 01,08 |
| Date Received | 2015-02-12 |
| Date of Report | 2015-02-11 |
| Date of Event | 2015-02-11 |
| Date Mfgr Received | 2015-02-11 |
| Date Added to Maude | 2015-02-12 |
| 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 | 0 |
| Manufacturer Contact | SANDRA O'REILLY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| 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 | PHOENIX HANDPIECE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION HANDPIECE |
| Product Code | MNO |
| Date Received | 2015-02-12 |
| Model Number | HP-PHX |
| Lot Number | TA-04065 |
| Operator | PHYSICIAN |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-02-12 |