MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60SF2

Device Problem Device Handling Problem (3265)

Patient Problem Vascular Dissection (3160)

Event Date 06/01/2009

Event Type  Injury  

Manufacturer Narrative

Literature article: coronary artery dissection after surgical cryoablation procedure (ann thorac surg 2009;87:1946 ¿ 8) fabien doguet, md et al doi: 10.1016/j.Athoracsur.2008.11.009.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a case of circumflex artery injury in a (b)(6)-year-old woman who had undergone mitral valve replacement, tricuspid annuloplasty, and an atrial fibrillation (af) cryoablation procedure.All data was collected from a single center.A medtronic cryoflex probe was used for the cryoablation procedure (serial or model numbers not provided).Four hours post-surgery, electrocardiographic changes were observed in the circumflex artery territory associated with hemodynamic instability, which responded to inotropic agents.Angiography revealed a diffuse circumflex artery spasm with a heterogeneous aspect of the posterior branch evoking a dissection.Platelet anti-aggregant and trinitrine therapy were started.Recovery was uneventful and the patient was discharged on day 13.Based on the available information, the circumflex artery injury may have been attributed to medtronic product.No death or device malfunction occurred.No additional adverse patient effects or product performance issues were reported.

Event Description

Medtronic received information via literature regarding a case of circumflex artery injury in a 71-year-old woman who had undergone mitral valve replacement, tricuspid annuloplasty, and an atrial fibrillation (af) cryoablation procedure.All data was collected from a single center.A medtronic cryoflex probe was used for the cryoablation procedure (serial or model numbers not provided).Four hours post-surgery, electrocardiographic changes were observed in the circumflex artery territory associated with hemodynamic instability, which responded to inotropic agents.Angiography revealed a diffuse circumflex artery spasm with a heterogeneous aspect of the posterior branch evoking a dissection.Platelet anti-aggregant and trinitrine therapy were started.Recovery was uneventful and the patient was discharged on day 13.Based on the available information, the circumflex artery injury may have been attributed to medtronic product.No death or device malfunction occurred.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Following review of the complaint with medtronics office of medical affairs, it is our assessment that the type of issue observed would be the result of the concomitant procedure and not related to the medtronic device.The device was not returned for analysis.This investigation was completed with all the information that was provided.If additional information is received, this investigation will be reopened if deemed necessary.Medtronic will continue to monitor for future events.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 10238787
• MDR Text Key: 197748079
• Report Number: 3008592544-2020-00033
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K123733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 10/10/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR