MAUDE Adverse Event Report: SOLOGRIP III HANDPIECE; LASER THERAPY PRODUCT

Model Number HP-SG3

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Congestive Heart Failure (1783)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports from (b)(6) study, patient was hospitalized from (b)(6) 2017 for atrial flutter and adhf.Patient impact: on (b)(6) 2017: rehospitalization due to heart failure; congestive heart failure; ventricular arrhythmia.

Manufacturer Narrative

A review of the available information was performed.Tmr study subject was re-hospitalized from (b)(6) 2017 for atrial flutter and acute decompensated heart failure (adhf).This 63.2 year old male patient underwent tmr + cabg via sternotomy while on cardiopulmonary bypass on (b)(6) 2017.The patient¿s past medical history was significant for a preoperative ef of 45%, diabetes, previous myocardial infarction (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.The total procedure time was 281 minutes, of which 84 minutes were spent on cardiopulmonary bypass.A total of 30 channels were placed: 4 anterolateral, 4 posterolateral, and 22 inferior.Tmr was performed prior to the cabg procedure in which 3 vessels were grafted: left anterior descending, upper diagonal, and right pda.One vessel, om, was ungrafted as it was too small.The patient was discharged on (b)(6) 2017 (pod 6).According to the tmr study case report forms, the patient required re-hospitalization due to atrial flutter, congestive heart failure, and adhf.No additional information regarding the event was available.Thirty-day follow-up was performed on (b)(6) 2017, at which time the patient reported no angina.No additional events were reported during the 30-day follow-up period.During the 1-year follow-up period, the patient underwent percutaneous coronary intervention (e.G., ptca, stent) on (b)(6) 2018.No additional information is available regarding the nature of this event and no other adverse events were reported during the 1-year follow-up period.The patient reported no angina at 1-year follow-up on (b)(6) 2018.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).Heart failure occurs when the heart is unable to provide sufficient pump action to maintain blood flow to meet the needs of the body, and has been reported as one of the most common causes of hospital readmission following cabg (li).Thirty-day hospital readmission rates after isolated cabg vary in the literature, ranging from 7%- 24%, with an average of 15% (hannan, 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.Steuer et al.Performed a review of 7,493 patients discharged alive after undergoing primary cabg from 1987-1996, with 7.7% of patients (n= 576) readmitted for heart failure.Actuarial freedom from readmission from heart failure at 4 years was 93%, and 89% at 7 years.Hospital readmission rates due to heart failure for patients undergoing cabg with adjunctive tmr have also been reported.A, multi-center, blinded, prospective, randomized, controlled trial by allen et al.Recorded 30-day hospital rates of readmission due to heart failure in 5% for tmr + cabg patients, and 6% for patients who underwent cabg alone (p= 0.6).A retrospective review of 255 consecutive patients who required cabg by wehberg et al.Found 30-day readmission rates due to heart failure to be significantly reduced in patients who underwent adjunctive tmr+cabg vs.Patients who underwent cabg alone(2.8% vs.7.8%; p< 0.5).Similar to this patient, pre-operative co-morbidities, such as hypertension and diabetes (steuer, wehberg), have also been associated with a higher risk of hospital readmission following cabg, with rates of 13.8% vs.9.7%, p<0.0001; and 15.6% vs.11.3%, p<0.0001, respectively (steuer).Additionally, the effect of pre-operative myocardial injury (pmi), i.E.Previous myocardial infarction or irreversible myocardial injury, has been discussed in the literature as an important cause of complications following cardiac surgery.Steuer et al.Identified pmi as risk factor for developing heart failure after cabg, with 20% of patients readmitted for heart failure with pmi (multivariate hr 2.3, 95% ci 1.8- 2.8).History of previous myocardial infarction was also identified as an independent risk factor for development of heart failure after cabg (steuer).This event does not identify additional hazards or modify the probability and severity of existing hazards.No action necessary.This report is 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.

Event Description

According to initial reports from tmr study, patient was hospitalized from (b)(6) 2017 for atrial flutter and adhf.Patient impact: in (b)(6) 2017: rehospitalization due to heart failure; congestive heart failure; ventricular arrhythmia.

• Brand Name: SOLOGRIP III HANDPIECE
• Type of Device: LASER THERAPY PRODUCT
• MDR Report Key: 7973539
• MDR Text Key: 123969936
• Report Number: 1063481-2018-00042
• Device Sequence Number: 0
• Product Code: MNO
• Combination Product (y/n): N
• PMA/PMN Number: P970029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HP-SG3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/18/2018
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 64 YR