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); Perforation (2001); Vascular Dissection (3160)

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 related to a pre-existing condition or comorbidity was reported.One occurrence of embolism, dissection and arterial perforation were all reported to be related to the procedure but not directly to the device.The following malfunctions were reported during use of the export advance with no impact on the procedure: insertion difficulty, removal difficulty and catheter deformation.During use of the export ap, the complications reported included myocardial infarction, dissection, embolism, arterial perforation, hemorrhage and hypotension.The arterial perforation and the hemorrhage were reported to be related to a pre-existing condition or comorbidity.The hypotension was reported to be related to the procedure but not directly to the export ap device.Resistance was reported to have been encountered in one case and had no impact on the procedure.

• 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: 8973961
• MDR Text Key: 156890578
• Report Number: 1220452-2019-00114
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• 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
• 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