MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-02-13 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[67278614]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[67278615]
According to the report, "subject 026-901 was admitted to 6n med/surg on (b)(6) 2017 with chest pain and shortness of breath. Cta showed small bilateral pleural effusions and a trace right apical pneumothorax. She was placed on nasal cannula and diuresed with iv lasix with improvement in her shortness of breath. Her hyponatremia also improved with diuresis. She was assessed for home oxygen and found to be hypoxia with minimal exertion - she was arranged for home oxygen with portable tank delivered to her room. She clinically felt well and was discharged to home on (b)(6) 2017 with instructions to follow up with her pcp. "
Patient Sequence No: 1, Text Type: D, B5
[74719594]
According to the case report forms (crfs) and report the patient was admitted to the hospital on (b)(6) 2017 with chest pain and shortness of breath. Cta showed small bilateral pleural effusions and a trace right apical pneumothorax. She was placed on nasal cannula and diuresed with iv lasix with improvement in her shortness of breath. Her hyponatremia also improved with diuresis. She was assessed for home oxygen and found to be hypoxia with minimal exertion? She was arranged for home oxygen with portable tank delivered to her room. She clinically felt well and was discharged home on (b)(6) 2017 with instructions to follow-up with her pcp. ? The manufacturing records were reviewed for handpiece ta-04094. It was confirmed that all records were controlled, available for review, and met all specifications per the device master record. This (b)(6) female patient underwent tmr + cabg via sternotomy while on cardiopulmonary bypass on (b)(6) 2016. The patient? S past medical history was significant for a preoperative ef of 55%, diabetes, previous myocardial infarction [mi] (non q-wave mi within 2 weeks prior to the tmr procedure), hypertension (at any time), previous percutaneous coronary intervention (e. G. , ptca stent), and smoking (long history of? Heavy tobacco use? Per operative notes provided by the site). ? The total procedure time was 122 minutes, during which a total of 28 channels were placed: 11 anterolateral, 9 inferior, 8 anterior. Tmr was performed prior to the cabg procedure in which 3 vessels were grafted: left internal mammary artery to the left anterior descending artery, saphenous vein graft to obtuse marginal, saphenous vein graft to right posterior descending artery. The patient remained hospitalized after the tmr + cabg procedure through 30-day follow-up due leukocytosis, pleural effusion, and chylothorax. The patient went on to require surgery, ligation of the thoracic duct, to repair the chylothorax leak on (b)(6) 2017. Thirty-day follow-up was performed on (b)(6) 2017, at which the patient reported no angina. The patient was subsequently discharged on (b)(6) 2017. According to the operative report provided by the site, the patient had severe, diffuse multi-vessel artery coronary disease and was considered very high risk surgical patient due to very diffuse severe poor quality targets. The surgeon also stated that he did not think the cabg grafts would last a very long time as a result of the extent of the patient? S coronary disease and very poor quality targets. The patient was rehospitalized on (b)(6) 2017 with complaints of chest pain and shortness of breath. Cta showed a small bilateral pleural effusion and trace right apical pneumothorax. The patient was placed on nasal cannula and diuresed with iv lasix, with improvement in her shortness of breath. Per discharge summary notes provided by the site, the chest pain was determined to be chest wall pain as a result of her previous surgeries. The patient was found to be hypoxic with minimal exertion and assessed for home oxygen with a portable tank delivered to her room. The patient was discharged on (b)(6) 2017 with arrangements for home oxygen and instructed to follow-up with her pcp.? The patient was originally diagnosed with pleural effusions during her post-operative hospitalization following the tmr+cabg procedure. A chest x-ray performed on (b)(6) 2017 noted? Continued improvement in aeration with small residual effusions and atelectasis? , and chest cta performed on (b)(6) 2017 noted,? Right pleural effusion is decreased from (b)(6) 2017. "? The cause of the patient? S? Chest wall pain following surgery? (as reported in the discharge summary provided by the site), is related the patient? S previous sternotomy and thoracotomy procedures.? The cause of the shortness of breath and hypoxia is related to the patient? S discharge diagnosis of? Fluid overload? That was relieved by iv diuresis.? These condition described above are related the patient? S multiple comorbidities, including diabetes, hypertension, heavy tobacco use, previous cardiac surgeries, severe cardiac disease, and are not likely related to the tmr procedure.? The ifu provides the following instructions:? The safety and effectiveness of the cardiogenesis laser system has not been established for the following specific populations: patients who have experienced a non-q-wave myocardial infarction within the past 2 weeks.? The ifu lists the following potential adverse events that may occur with the use of tmr: pulmonary complications.
Patient Sequence No: 1, Text Type: N, H10
[74719595]
According to the crfs (case report forms) and report, the patient was to the hospital admitted on (b)(6) 2017 with chest pain and shortness of breath. Cta showed small bilateral pleural effusions and a trace right apical pneumothorax. She was placed on nasal cannula and diuresed with iv lasix with improvement in her shortness of breath. Her hyponatremia also improved with diuresis. She was assessed for home oxygen and found to be hypoxia with minimal exertion? She was arranged for home oxygen with portable tank delivered to her room. She clinically felt well and was discharged home on (b)(6) 2017
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00005 |
| MDR Report Key | 6326913 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-13 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-01-28 |
| Date Facility Aware | 2017-02-02 |
| Date Mfgr Received | 2017-02-02 |
| Date Added to Maude | 2017-02-13 |
| 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 | 2017-02-13 |
| 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 | 2017-02-13 |