MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM 002-3100 30W THERMAL THERAPY; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 002-3100

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Micturition Urgency (1871); Impotence (1925); Inflammation (1932); Pain (1994); Iatrogenic Source (2498)

Event Date 04/17/2015

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age and weight were not made available.No parts have been received by manufacturer for analysis as no malfunction was alleged.A medtronic representative, laser induced thermal therapy sr.Clinical specialist, followed up with the doctor and reported the following: the surgeon reported there was no malfunction of hardware, software, or disposable mdt product that caused the rectourethral fistual.The patient had been previously treated with radiation therapy and the surgeon hypothesized that the wall was weakened by the radiation therapy and was not able to recover in the way that normal healthy tissue would.These type of patients now get a trans-perineal approach rather than a trans-rectal approach.Those who experienced erectile dysfunction were all bilateral ablations and, according to the doctor, there was no malfunction of hardware, software, or disposable mdt product, that caused the issue.He also mentioned that he is familiar with the safe medical devices act and knows the reporting procedure if he ever does experience a malfunction.The other minor complications mentioned in the article are known risks of prostate surgery.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's system 002-1100 15w thermal therapy.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.Part not received by manufacturer.

Event Description

Report comes from article abstract review: focal laser ablation of prostate cancer - technique and outcomes in 85 patients.Focal laser ablation of prostate cancer (fla) is a new technique to treat organ-confined tumors using magnetic resonance (mr) guidance and thermometry.We treated 85 patients with fla since june of 2013.Patients included in this group had focal lesions (1-3) visible by mri that were biopsy-proven prostate cancer graded less than gleason 8.Ineligible patients had large lesions (over 2 cm), extracapsular tumor spread, metastases or absolute contraindications to mri.All patients in this study filled out pre-treatment sexual health in men (shim) score sheets as well as the international prostate symptom score sheet (ipss) to obtain baseline erectile and urinary function.Men repeated such scoring at 6 and 12 months, then yearly.The fla procedure involved insertion of an endorectal needle guide and imaging in a 3 tesla mri.After the probe was calibrated to the mri sequences, we guided a 13g plastic cooling cannula through each lesion.Typically, fla involved irradiation with 65-70% of 24 watt diode laser energy for 2-3 minutes per ablation mri thermometry projected color-coded maps showing cell death as it occurred during the fla process.Patients were discharged after they voided clear urine.Mr and psa follow up occurred at 6 months, one year and then yearly after the fla procedure.All procedures were technically successful.One major complication occurred with development of a rectourethral fistula post fla.Minor side effects included urgency for 1-5 days (n=4), groin pain for 1-2 weeks (n=4), and epididymitis (n=1).Only two patients had new erectile dysfunction after fla: both had bilateral fla procedures.Of the 85 patients, 6 (7%) required a second fla procedure.Tests of urinary and sexual function did not differ at 6 months (25 patients with shim scores averaging 21.6 pre fla and 20.4 post fla p=0.66 and ipss scores averaging 7.6 pre fla and 7.2 post fla, p=0.58) nor at 12 months for a limited group of 7 patients (shim scores averaging 19 pre fla and 20.6 one year post fla, p=0.43 and ipss scores averaging 8.9 pre fla and 8.9 one year post fla, p=0.47).In conclusion, fla for low or intermediate risk prostate cancer is safe and requires few retreatments (about 7%).Fla has no significant impact on a man's sexual or urinary function although bilateral disease should be treated with caution.In selected cases, focal therapy of prostate cancer can be considered as primary therapy, as it is already in many other organ systems.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's system 002-1100 15w thermal therapy.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

Correction: the narrative blocks of the initial mdr inadvertently referenced a 15w system.The narrative should have referenced the "system 002-3100 30w thermal therapy.".

Manufacturer Narrative

In addition to the information already reported, a patient survey and prostate cancer treatment comparison chart were also received along with the article previously submitted/reported under this mdr number.Some of the patients surveyed were the same patients who were included in the previously attached study.It cannot be determined which patient responses correspond with data already submitted.Results of the survey are as follows.Patient survey review: focal laser ablation of prostate cancer¿technique and outcomes in 75 patients: 94% of 75 patients reported no significant ed; 92%% had no significant urinary problems; 84% reported no significant pain or other complications.Patient survey identified the use of catheter to protect urethra during some fla procedures caused for 24 - 36 hours after treatment a sense of urgency or discomfort during urination.Per one of the surgeons, none of the patient's urinary complications or erectile dysfunction were permanent that he is aware of.2 patients had 12-18 months recovery.True recurrences were attributable to not taking enough margin due to outmoded technology (1.5t, mapping software, narrow laser beams) and possibly the physician¿s underestimation of the margin that is needed.Per email from surgeon regarding what "narrow laser beams" meant: "we are simply learning that the treatment of focal prostate cancer requires wide margins that cannot be achieved with the smaller 400 micron blue fiber or with low intensity laser (less than 15w).Nothing related to the visualase laser or software component performance.".

• Brand Name: SYSTEM 002-3100 30W THERMAL THERAPY
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 5101035
• MDR Text Key: 26718381
• Report Number: 1723170-2015-01068
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 002-3100
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability