MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,07 report with the FDA on 2015-04-07 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[15914065]
The patient received tmr on (b)(6) 2015 with cabg procedure. The patient received 16 tmr channels. Patient had a history of mi (non-q-wave within 2 weeks of tmr), hypercholesterolemia, hypertension, pci, and smoking. The patient was male with 45% pre-operative ejection fraction and was 73 years old. Patient had atrial fibrillation on three occasions when still in hospital after the procedure ((b)(6) 2015) and was rehospitalized on (b)(6) 2015 for shortness of breath.
Patient Sequence No: 1, Text Type: D, B5
[16016454]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report. This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event. Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
Patient Sequence No: 1, Text Type: N, H10
[39225939]
The patient received tmr on (b)(6) 2015 with cabg procedure. The patient received 16 tmr channels. Patient had a history of mi (non-q-wave within 2 weeks of tmr), hypercholesterolemia, hypertension, pci, and smoking. The patient was male with 45% pre-operative ejection fraction and was (b)(6). Patient had atrial fibrillation on three occasions when still in hospital after the procedure ((b)(6) 2015) and was rehospitalized on (b)(6) 2015 for shortness of breath. Additional information received from the facility indicated the shortness of breath was due to left pleural effusion which was treated with a thoracentesis. Shipping records indicated the following possible sologrip iii handpiece lot numbers were sent to the hospital in the six months prior to the procedure: (b)(4). The manufacturing and inspection records were reviewed for the three possible lots. All approved units underwent final testing and inspection and received passing results. Through review of the manufacturing and inspection records, no root cause of the reported event could be determined. According to all documentation the approved handpieces and their subassemblies were constructed from approved components and passed all final testing. A review was performed of the available information. The patient with class iv angina received tmr in adjunct to a cabg procedure. Sixteen tmr channels were created in the posterolateral side of the heart. Tmr and cabg were performed through a sternotomy and the patient was on bypass for 57 minutes. The total procedure time was 114 minutes, of which 1. 5 minutes was laser procedure. The cabg procedure was performed prior to tmr. The experienced three episodes of atrial fibrillation while still in the hospital on days 1, 5, and 6 postoperative. The patient was discharged eight days after the tmr+cabg procedure. Four days later, the patient was hospitalized for shortness of breath due to pleural effusion. At the follow-up visit, 41 days after the procedure, the patient did not have angina. 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. Additionally, af has been recorded in tmr + cabg patients. Allen et al. 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%. 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). In addition to the af, the patient was also re-hospitalized for shortness of breath due to pleural effusion. Postoperative pleural effusions are common in patients undergoing cardiac surgery, and one of the most frequently reported complications following cabg. At least 40% of patients who undergo cabg develop a pleural effusion in the immediate postoperative period. In fact, cabg has been cited as the fifth leading cause of pleural effusion after congestive heart failure, pneumonia, malignancy, and pulmonary embolism. The incidence of pleural effusion following cabg varies in the literature, ranging from 42%-89%. A prospective study of 47 patients undergoing elective cabg surgery by vargas et al. (1994) cited a pleural effusion rate of 89. 4% (n=42) at post-operative day seven. A report by light et al. (2002) compared rates of pleural effusion for patients undergoing cabg alone (n=312) to that of cabg+valve replacement (n=37). Rates of pleural effusion for cabg alone and cabg+valve replacement were virtually identical, at 62. 4% and 60. 5%, respectively. Despite high rates of post-operative pleural effusion in patients undergoing cabg and cardiac surgery, the vast majority are reported to follow a benign course, improve gradually over time, and require little to no intervention. Explanation for the occurrence of pleural fluids and subsequent elevated incidence of pleural effusions following cabg remains unclear, and is likely multifactorial. Multiple etiologies have been discussed in the literature, including the presence of heart failure, postcardiac injury syndrome, atelectasis, chest tubes, pleural injury from pleurotomy, or pericardial inflammation. Pleural trauma directly associated with the procedure itself is the most common theory reported in the literature. Both atrial fibrillation and pleural effusion are common events after cabg and other cardiac procedures. Af is a common dysrhythmia seen in patients with other cardiovascular diseases and events such as hypertension, hypercholesterolemia, and previous myocardial infarction, which were noted in this patient's medical history. In addition, transient dysrhythmias are known to occur following a tmr procedure. Adequate precautions and warnings are present in the product's instructions for use (ifu).
Patient Sequence No: 1, Text Type: N, H10
[39225940]
The patient received tmr on (b)(6) 2015 with cabg procedure. The patient received 16 tmr channels. Patient had a history of mi (non-q-wave within 2 weeks of tmr), hypercholesterolemia, hypertension, pci, and smoking. The patient was male with 45% pre-operative ejection fraction and was (b)(6). Patient had atrial fibrillation on three occasions when still in hospital after the procedure ((b)(6) 2015) and was rehospitalized on (b)(6) 2015 for shortness of breath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00039 |
| MDR Report Key | 4664660 |
| Report Source | 02,07 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-04-07 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-04-07 |
| Date Added to Maude | 2015-04-07 |
| 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 | 2015-04-07 |
| 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 | 2015-04-07 |