MAUDE Adverse Event Report: MEDTRONIC, INC EXPORT AP ASPIRATION CATHETER; CATHETER, EMBOLECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

Journal: international journal of surgery case reports title: staged acute mesenteric and peripheral ischemia treatment in covid-19 patient: case report reference: doi.Org/10.1016/j.Ijscr.2021.106105.Date of publication medication: dual antiplatelet therapy and low molecular weight heparin.If information is provided in the future, a supplemental report will be issued.

Event Description

A case report titled; staged acute mesenteric and peripheral ischemia treatment in covid-19 patient: case report, was submitted.A patient presented to hospital with covid-19 interstitial pneumonia with fever and dyspnea.The pulmonary ct scan showed the typical finding of covid 19 infection and severe acute respiratory syndrome coronavirus 2 (sars- cov-2) with the typical interstitial pneumonia infection.Forty eight hours after being admitted the patient reported acute onset of abdominal pain and signs of acute abdomen and acute mesenteric ischemia (ami).Abdominal ct-angiography showed superior mesenteric artery (sma) origin stenosis and occlusion.A surgical attempt with sma thrombectomy was excluded due to the high surgical risk mainly related to respiratory impairment and on this basis, an endovascular approach was chosen.The patient was treated by mechanical thrombectomy using a 6f export ap aspiration catheter and proximal sma balloon-expandable uncovered non mdt stenting to restore sma patency.At 24 h from the index operation, the ct-angiography confirmed sma patency with a non-significant residual thrombus on the artery wall and maintenance of sma distal flow.Postoperative medical management consisted of dual antiplatelet therapy and low molecular weight heparin.Seven days post procedure, the patient presented with right leg rest pain and foot cyanosis.Duplex ultrasound showed a right femoropopliteal artery thrombosis and acute limb ischemia.The patient was treated with a hybrid surgical transfemoral thrombectomy and distal superficial femoral artery stenting due to a residual dissection.24 hours post the second procedure the leg appeared normothermic with a good popliteal pulse and dus confirmed patent femoro-popliteal arteries.The patient showed a significant decline of respiratory function which required intensive care management and patient death occurred due to acute respiratory failure, 12 days post the first procedure and 5 days post the second intervention.Please note that this device (export ap catheter) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (export ap).

Manufacturer Narrative

Additional information: procedural images/data in the article provided the basis of the analysis.The images in the article confirm the presence of a thrombus in the superior mesenteric artery.Annex d code added correction: annex g code updated 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: EXPORT AP ASPIRATION CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 12431561
• MDR Text Key: 272541919
• Report Number: 1220452-2021-00041
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR