MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2015-01-16 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[19798772]
According to the report received from (b)(6), the patient underwent a cabg+tmr procedure on (b)(6), 2014 with a total of 18 channels placed. The patient experienced atrial fibrillation on (b)(6), 2014 and was hospitalized for congestive heart failure on (b)(6), 2014.
Patient Sequence No: 1, Text Type: D, B5
[20053151]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[36876812]
The corrected possible lot numbers sent to the hospital in the six months prior to the procedure (03/01/2014 - 09/04/2014) include ta-04031, ta-04032, ta-04034, and ta-04035.
Patient Sequence No: 1, Text Type: N, H10
[36876813]
According to the report received from the (b)(6) registry, the patient underwent a cabg+tmr procedure on (b)(6) 2014 with a total of 18 channels placed. The patient experienced atrial fibrillation on (b)(6) 2014 and was hospitalized for congestive heart failure on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[37870243]
According to the report from cryolife project director, a patient from the angina relief registry underwent a coronary artery bypass grafting (cabg) and transmyocardial revascularization (tmr) procedure on (b)(6) 2014 with a total of 18 channels placed. The patient experienced atrial fibrillation on (b)(6) 2014 and was hospitalized for congestive heart failure on (b)(6) 2014. Multiple attempts were made via email on (b)(6) 2015 to obtain lot numbers for the tmr handpieces but were not successful. The shipping log indicated possible lot numbers ta-04031, ta-04032, ta-04034, ta-04035, ta-04041, ta-04043, and ta-04045. No root cause for this complaint could be identified through review of the manufacturing and inspection records. According to the contract manufacturer's documentation, all approved handpieces were constructed appropriately with approved components, passing quality testing and final inspection. According to the available information, the (b)(6) patient underwent tmr as an adjunct to cabg and left carotid endarterectomy while on cardiopulmonary bypass on (b)(6) 2014. The patient was male with a history of congestive heart failure, diabetes, previous myocardial infarction (mi, non q-wave two weeks prior to procedure), family history of coronary artery disease (cad), hypercholesterolemia, hypertension, previous cabg, and smoking. Pre-operative ejection fraction was 30%. The total procedure time was 184 minutes, of which 65 minutes were spent on cardiopulmonary bypass. The total laser time was 2 minutes and 18 channels were placed on the heart: 6 channels on the anterolateral and 12 channels on the posterolateral aspects of the heart. The cabg and left carotid endarterectomy procedures took place before tmr, in which two grafts were placed. On (b)(6) 2014, three days after the procedure, the patient experienced atrial fibrillation. The patient was discharged from hospital fourteen days after the procedure on (b)(6) 2014. On (b)(6) 2014, the patient was rehospitalized due to congestive heart failure. Atrial fibrillation (af) is an irregular heart beat and is a common early adverse event after cardiac surgery. In fact, up to 40% of cabg patients experience post-operative atrial fibrillation (wehberg, allen, zaman). Additionally, af has been recorded in tmr + cabg patients. Allen et al (2000) recorded 24% af in tmr+cabg patients and 21% in cabg patients in a randomized controlled trial (rct). The occurrence of af in stand-alone tmr patients was less, reported at 10% (allen, 1999). Additionally, a retrospective review of patients who received cabg alone, from wehberg {2003), showed a statistical decrease in af after tmr+cabg compared to cabg {16. 7 vs. 37. 4%; p=0. 025). Heart failure occurs when the heart is unable to provide sufficient pump action to maintain blood flow to meet the needs of the body (li). Congestive heart failure has been reported as on the most common causes of hospital readmission following cabg (li). An rct by allen et al. Reported a 5% rate of congestive heart failure (chf) in 5% of tmr+cabg patients, and 6% for patients who underwent cabg alone (allen, 2000). A rct by frazier et al. Reported similar rates of chf, with 5% in tmr+cabg patients, and 5% for cabg alone. Thirty-day hospital readmission rates after isolated cabg vary in the literature, ranging from 7%- 24%, with an average of 15% (li). A retrospective review of the 2009 california cabg clinical registry and hospital discharge data from 119 hospitals was performed by li et al. To identify all causes of 30-day hospital readmission in 11,823 patients discharged alive after isolated cabg. The rate of 30-day readmission was 13. 2% (n= 1,565), with heart failure identified as the most common cause for readmission, occurring in 15. 3% (n= 239) of these patients (li). The instructions for use (ifu) lists arrhythmia, conductive pathway injury and pulmonary complications as potential adverse events associated with the use of the sologrip iii. This complaint suggests that the patient presented with a common adverse event following the procedure, it does not appear to be related to the handpiece.
Patient Sequence No: 1, Text Type: N, H10
[37870244]
According to the report received from the angina relief registry, the patient underwent a cabg+tmr procedure on (b)(6) 2014 with a total of 18 channels placed. The patient experienced atrial fibrillation on (b)(6) 2014 and was hospitalized for congestive heart failure on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00002 |
| MDR Report Key | 4427758 |
| Report Source | 02,05 |
| Date Received | 2015-01-16 |
| Date of Report | 2014-12-11 |
| Date of Event | 2014-09-08 |
| Date Mfgr Received | 2014-12-11 |
| Date Added to Maude | 2015-01-16 |
| 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 REVASCULARLIZATION LASER HANDPIECE |
| Product Code | MNO |
| Date Received | 2015-01-16 |
| Model Number | HP-SG3 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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; 2. Other | 2015-01-16 |