MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2017-02-20 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife Inc.
[67805828]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[67805829]
Email received from research coordinator stated: "good morning (b)(6), i completed the 30 day follow up on subject (b)(6) today. He was rehospitalized on (b)(6) 2017 for dyspnea and swelling in the lower extremities. Please let me know if you need me to submit any additional documentation. " date of tmr procedure (b)(6) 2016 also concomitant coronary artery bypass grafting. Case report forms indicate the following: principle investigator "attributes this to heart failure. During admission [(b)(6) 2017], he was found have atrial flutter and will be going to a consult for icd placement. "
Patient Sequence No: 1, Text Type: D, B5
[73355637]
the manufacturing records for the hp-sg3, sn (b)(4), were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. All lots passed functional testing and met release specifications.
a (b)(6) male patient underwent tmr+ cabg via sternotomy while on cardiopulmonary bypass on (b)(6) 2016. The total procedure time was 211 minutes. A total of 29 tmr channels were placed: 5 anterolateral, 5 posterolateral, 8 inferior, and 11 anterior. Cabg was performed after the tmr procedure placing a graft on ascending aorta, left anterior descending, and obtuse marginal. The patient was discharged from the hospital on (b)(6) 2017. On (b)(6) 2017, the patient was hospitalized for dyspnea, leg swelling, and diagnosed with heart failure. The patient had atrial flutter and radiofrequency ablation occurred. The patient was discharged on (b)(6) 2017. On a 30-day follow-up (b)(6) 2017, the patient was reported to be angina free. Per operative notes, the patient? S pre-operative diagnosis included: severe multi-vessel coronary disease, congestive heart failure, decompensated congestive heart failure, and an ef of? Only about 20%?.
further investigation informs one of sologrip? S instructions for use (ifu). The ifu noted that in an approved study patients, who underwent tmr, with ef =30% were at greater risk of death compared to those with ef=30%. However, nothing prohibits the use of tmr in patients with ef? S =30%. The specific patient populations information located in the patient selection and treatment section of the ifu do note that safety and effectiveness of the cardiogenesis laser system has not been established in patients with a left ventricular ef =25%. In conclusion, readmission of patient due to previous complications:? Cause of readmission, and associated dyspnea and leg swelling, is an acute exacerbation of pre-existing decompensated heart failure in patient with multiple co-morbidities, including a low ejection fraction of <20% and atrial arrhythmia.
the root cause of readmission and associated dyspnea and leg swelling is "an acute exacerbation of pre-existing decompensated heart failure in patient with multiple co-morbidities, including a low ejection fraction of <20% and atrial arrhythmia. " the ifu states: "in the post approval study of 358 patients treated with either the sologrip iii or pearl 5. 0 handpiece, patients with ejection fractions =30% were at higher risk of death compared to patients with ejection fractions > 30%. "
no further action necessary. This event does not identify additional hazards or modify the probability and severity of existing hazards.
Patient Sequence No: 1, Text Type: N, H10
[73355638]
Email received from research coordinator stated: "good morning [cryolife cardiac specialist], i completed the 30 day follow up on subject (b)(6) today. He was rehospitalized on (b)(6) 2017 for dyspnea and swelling in the lower extremities. Please let me know if you need me to submit any additional documentation. " date of tmr procedure (b)(6) 2016 also concomitant coronary artery bypass grafting. Case report forms indicate the following: principle investigator "attributes this to heart failure. During admission [(b)(6) 2017], he was found have atrial flutter and will be going to a consult for icd placement. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00006 |
| MDR Report Key | 6344021 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2017-02-20 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-01-20 |
| Date Facility Aware | 2017-01-23 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-02-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW. |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| 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 | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Product Code | MNO |
| Date Received | 2017-02-20 |
| Model Number | HP-SG3 |
| Lot Number | TA-04094 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-02-20 |