MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2015-04-23 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[5580519]
Study patient (b)(6) underwent aortic valve replacement on (b)(6) /2003 with concomitant coronary artery bypass grafting (cabg) and transmyocardial revascularization (tmr). The patient experienced wide complex sinus tachycardia and died on (b)(6) 2003. Cause of death ruled respiratory and cardiac arrest. This investigation is in reference to the tmr handpiece.
Patient Sequence No: 1, Text Type: D, B5
[13172661]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[17579824]
Study patient (b)(6) ((b)(6) study) underwent aortic valve replacement on (b)(6) 2003 with concomitant coronary artery bypass grafting (cabg) and transmyocardial revascularization (tmr). The patient experienced wide complex sinus tachycardia and died on (b)(6) 2003. Cause of death ruled respiratory and cardiac arrest. This investigation is in reference to the tmr handpiece.
Patient Sequence No: 1, Text Type: D, B5
[17768131]
According to the case report forms (crfs), operative notes and the initial report, the patient underwent aortic valve replacement on (b)(6) 2003 with concomitant cabg, tmr (hp-sg3, lot number unknown), and atrioventricular pacemaker placement. The patient experienced wide complex sinus tachycardia and died on (b)(6) 2003. Cause of death ruled respiratory and cardiac arrest. As noted in the patient medical history captured in the crfs and the operative notes (provided on 04/28/2015), the indications for the procedure on (b)(6) 2003 was coronary artery disease with aortic insufficiency, status post ascending aortic dissection ((b)(6) 2002). Preoperative transthoracic echocardiogram (tee) on (b)(6) 2003 revealed and ejection fraction (ef) of 51% and mild insufficiency (+1). The cardiac cath and doppler from (b)(6) 2003 indicated the following: aortic root 3. 6 cm, left ventricle normal size, left atrium enlarged with mild hypokinesia of inferior wall, small pericardial effusion, aortic leaflets slightly thickened with tri-leaflet configuration, atrial valve with normal flow and velocity with mild-moderate atrial regurgitation, mitral annular calcification, trace mitral regurgitation, normal pulmonary artery pressure, and severe multi-vessel coronary artery disease (cad). The cardiac related complications on (b)(6) 2003 were diagnosed as agonal respirations, wide complex tachycardia, cardiac arrest, and respiratory arrest. The cause of death was ruled cardiac and respiratory arrest. According to the crfs, the patient was a (b)(6) female with moderate chronic lung disease, > 8 alcoholic drinks per week, chronic obstructive pulmonary disease, cigarette smoking, hypertension, oxygen use at home, chronic back pain, previous myocardial infarction (mi), coronary artery disease, aortic dissection, increased liver function tests, pulmonary edema, fibromyalgia, coronary artery bypass grafts (cabg), stents, angioplasty, shortness of breath, pneumonia, arthritis and depression. Previous cardiac surgical history included cabg ((b)(6) 2002), ascending aortic dissection repair ((b)(6) 2002), previous stent implant ((b)(6) 2002), and angioplasty. Prior to the surgery, the patient was nyha class iv, ejection fraction of 51% with mild aortic insufficiency. The patient underwent a sternotomy and had an aortic allograft implanted, tmr and cabg. From the operative notes, "the coronary arteries were noted to be diffusely diseased distally with extremely small vessels and severe diffuse disease, which made complete revascularization difficult. Therefore transmyocardial laser revascularization was done with a total of 20 channels being placed; most in the posterolateral walls. " patients who undergo tmr in adjunct to cabg have an area of the left ventricle that is not able to be vascularized by cabg alone, which occurs in up to 25% of all cabg procedures (weintraub, 1994). Incomplete revascularization has been shown to be a predictor of early and late adverse events and operative mortality (graham, 1999 and osswald, 2001). A meta-analysis that evaluated tmr+cabg compared to cabg alone acknowledged that there are few randomized controlled trials evaluating these (tmr+cabg) patients (cheng, 2006). However, the data that is available indicated that adjunctive tmr reduced early major cardiac events (mace), improved 30 day survival and exercise tolerance at 6 and 12 to 18 months. The thirty day mortality ranged from 0-31% in the tmr+cabg group, and 0-28% in the cabg alone group (allen, 2000 and 2004, frazier, 2004, loubani, 2003). For adjunctive tmr, one publication reported reduced early mortality and 1-year mortality in the tmr-cabg group; however at 5 years, this difference did not persist (allen, 2000 and 2004). An early sudden mortality after a cabg procedure with or without adjunctive tmr is not unexpected. Randomized controlled trials have shown thirty-day mortality ranging from 0-13% in the tmr+cabg group and 0-28% in the cabg alone group. For adjunctive tmr, one publication reported reduced early mortality and 1-year mortality in the tmr-cabg group; however at 5 years, this difference did not persist (allen, 2000 and 2004). The patient's history is remarkable for severe coronary artery disease, myocardial infarction, and myocardial dysfunction noted on a coronary cath performed on (b)(6) 2003. The cause of the sudden cardiac death was likely a lethal arrhythmia. Postoperative arrhythmias are a known complication of tmr, however the patient's preexisting medical conditions were likely significant contributing factors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2015-00052 |
| MDR Report Key | 4725065 |
| Report Source | 02,05 |
| Date Received | 2015-04-23 |
| Date of Report | 2015-04-14 |
| Date of Event | 2003-03-13 |
| Date Added to Maude | 2015-04-23 |
| 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 | SOLOGRIP III HANDPIECE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION HANDPIECE |
| Product Code | MNO |
| Date Received | 2015-04-23 |
| Model Number | HP-SG3 |
| 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. Death | 2015-04-23 |