MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number UNK-CV-SR-ENDURANT

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

Patient Problems Hypovolemic Shock (1917); Ischemia (1942); Pain (1994); Pneumonia (2011); Perforation of Vessels (2135); Pseudoaneurysm (2605); Constipation (3274)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic were informed of the following literature article; short-term outcome and mid-term access site complications of the percutaneous approach to endovascular abdominal aortic aneurysm repair (pevar) after introduction in a vascular teaching hospital.Hanneke p.F.X., moonen olivier h.J., koning ronald f van den haak, bart a n verhoeven, jan willem hinnen.Https://doi.Org/10.1007/s12928-018-0547-4.Note: patient death(s) were also included in the results of the journal article, however no causal link suggesting that the medtronic device(s) used in the patient cohort may have caused or contributed to the death(s) was provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Endurant stent grafts were used in the endovascular treatment of abdominal aortic aneurysms using a percutaneous approach.The following events were noted; serious injury; dissection, ischemia, uti, pneumonia, hemorrhagic shock, femoral hematoma, pseudoaneurysm, pain, constipation.

Manufacturer Narrative

Additional information received; it was confirmed by the journal article author that the medtronic devices were not considered or suspected to be a contributory cause to the adverse events noted in this articles.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 8850600
• MDR Text Key: 152951496
• Report Number: 9612164-2019-03181
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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 Model Number: UNK-CV-SR-ENDURANT
• Device Catalogue Number: UNK-CV-SR-ENDURANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/12/2019
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 74 YR