MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2015-01-22 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[5391797]
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 19 channels placed. The patient experienced atrial fibrillation on (b)(6) 2014 and was discharged from the hospital on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[12763884]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[33368000]
According to the report, a patient underwent a coronary artery bypass grafting (cabg) and transmyocardial revascularization (tmr) procedure on (b)(6) 2014 with a total of 19 channels placed. The patient experienced atrial fibrillation on (b)(6) 2014 and was discharged from the hospital on (b)(6) 2014. Multiple attempts were made to obtain lot numbers for the tmr handpieces but were not successful. Possible lot numbers may include ta-04031, ta-04032, ta-04034,ta-04035, ta-04041, and ta-04043. 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 while on cardiopulmonary bypass. The patient has a history of diabetes, family history of coronary artery disease (cad) before age 55 (blood relatives only), hypercholesterolemia, hypertension, and smoking. The pre-operative ejection fraction (ef) was 55%. The total procedure time was 120 minutes, of which 62 minutes were spent on cardiopulmonary bypass. The total laser time was 2 minutes and 19 total channels were placed on the heart: 8 channels on the anterolateral and 11 channels on the posterolateral aspects of the heart. The cabg procedure took place before tmr, in which three grafts were placed to the left anterior descending coronary artery (lad), obtuse marginal branch of main artery (om), and patent ductus arteriosus (pda). Three vessels, diagonal 1, diagonal 2, and om3 were too small and not grafted. On (b)(6) 2014, 19 days after the procedure, the patient experienced atrial fibrillation. The patient was subsequently discharged from the hospital on (b)(6) 2014. 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 or 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). Atrial fibrillation is a common dysrhythmia seen in patients with other cardiovascular diseases such as hypertension, hypercholesterolemia, diabetes and coronary artery disease which were noted in this patient's medical history. The instructions for use (ifu) lists arrhythmia and conductive pathway injury 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
[33368001]
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 19 channels placed. The patient experienced atrial fibrillation on 11/02/2014 and was discharged from the hospital on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[37874859]
According to the case report forms (crf) the date of discharge from the hospital was (b)(6) 2014.
Patient Sequence No: 1, Text Type: N, H10
[37874860]
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 19 channels placed. The patient experienced atrial fibrillation on (b)(6) 2014 and was discharged from the hospital on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00007 |
| MDR Report Key | 4443133 |
| Report Source | 02,05 |
| Date Received | 2015-01-22 |
| Date of Report | 2014-12-12 |
| Date of Event | 2014-11-02 |
| Date Mfgr Received | 2014-12-12 |
| Date Added to Maude | 2015-01-22 |
| 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 | 2015-01-22 |
| 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. Other | 2015-01-22 |