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

Model Number EXPORTAP

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

An attempt was made to use one 6f export ap catheters to treat a lesion.The device was inspected before use with no issues noted.The device was prepared per the ifu with no issues noted.It was reported that the export catheter was inserted and tracked along a guidewire into a mildly tortuous, mildly calcified lesion with 90% stenosis in the mid posterior interventricular artery (pda).Resistance was not encountered when advancing the device, excessive force was not used during delivery.The distal right coronary artery (rca) and posterior interventricular artery (pda) bifurcation was stented as a result, of in stent restenosis (irs) from a bare metal stent (bms) which had been implanted 9 years previously.It was noticed that plaque had shifted therefore the export device was being used to aspire the thrombus in the posterior interventricular artery (pda).After advancing the device distally an attempt was made to slowly pull back the export device.Resistance was encountered and both the 0.014¿ wires and the export catheter were remov ed.It was stated that one of the wires may have wrapped on the export device.There was significant damage to at least one of the 0.014¿ wires and throughout the distal portion of the export device.The device was not excessively torqued.The posterior interventricular artery (pda) was rewired with a new wire and a new export catheter was advanced.The thrombus was successfully aspired from the vessel.The patient is reported to be alive with no injury.

Manufacturer Narrative

Additional information: the non-medtronic guidewires were inspected and prepared per the ifu prior to use.Both guidewires were used simultaneously with the export device.Removal difficulties were only experienced when pulling back the export device over the non-medtronic guidewires.When pulling back the export device resistance was felt, and both wires began to come out with the export device.Both of the wires and the export were pulled.No intervention was required to remove the export device and the non-medtronic guidewires from the patient, they were pulled back through the guide and out of the body.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.

Manufacturer Narrative

Product analysis: one 6f export ap catheter was received for analysis.The device returned with a section of a non-medtronic guidewire wrapped around the proximal end of the shaft.Kinks were evident on the shaft of the device approx.0cm, 27cm and 29cm distal to the strain relief.Deformation was evident to the guidewire lumen of the device.At the proximal end of the guidewire lumen, the lumen was torn, and the lumen had lifted from the shaft of the device.Approx.4.5cm of the lumen had lifted from the shaft of the device.It was not possible to load an in-house 0.014¿ guidewire through the device due to the deformation noted.The markerband was still present and there was no deformation noted to the tip.No other damage evident to the remainder of the device.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
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15913175
• MDR Text Key: 305107100
• Report Number: 1220452-2022-00091
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00613994431745
• UDI-Public: 00613994431745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: EXPORTAP
• Device Catalogue Number: EXPORTAP
• Device Lot Number: 0010936070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 01/03/2023; 02/08/2023
• Supplement Dates FDA Received: 01/26/2023; 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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 Sex: Male