MAUDE Adverse Event Report: MEDTRONIC, INC ADVANCE; CATHETER, EMBOLECTOMY

Catalog Number UNK-CV-DAN-EXP-ADV

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

Patient Problems Embolism (1829); Myocardial Infarction (1969)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to collect postmarket information on the safety and performance of the medtronic family of aspiration catheters (export advance and export ap).Interventional cardiologists who use the devices participated in the survey to help confirm use of the devices and to ensure medtronic is aware of all potential complications associated with the use of export advance and export ap devices.During use of the export advance, one occurrence of myocardial infarction was reported to be related to a pre-existing condition or comorbidity and one occurrence of embolism was reported to be related to the procedure but not directly to the device.During use of the export advance, catheter deformation with no procedural impact occurred in one case.It was stated that the physician's standard use of medtronic aspiration catheters differs from what is described in the ifu in that they perform several rotations back and forth.During use of the export ap, myocardial infarction was reported for one patient and embolism directly related to the device as a result of thrombus formation was reported for one patient.Catheter deformation with no procedural impact also occurred in one case.It was stated that the physician's standard use of medtronic aspiration catheters differs from what is described in the ifu in that they leave the device in aspiration mode.

Manufacturer Narrative

Correction: pma / 510(k) #: k152335 was not submitted in the original report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADVANCE
• 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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8973774
• MDR Text Key: 156885795
• Report Number: 1220452-2019-00111
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K152335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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 Catalogue Number: UNK-CV-DAN-EXP-ADV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 09/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1