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

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

Patient Problems Cardiopulmonary Arrest (1765); Fistula (1862); Unspecified Infection (1930); Transient Ischemic Attack (2109); Rupture (2208); Respiratory Failure (2484)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from the journal article entitled; late surgical conversions after abdominal endovascular aortic repair: underlying mechanisms, clinical results and strategies for prevention.Https://doi.Org/10.1093/icvts/ivz207 andrzej juraszek, bartosz rylski, stoyan kondov, johannes scheumann, maximilian kreibich, julia morlock, holger schröfel, tim berger, fabian kari, matthias siepe, friedhelm beyersdorf, and martin czerny interactive cardiovascular and thoracic surgery, volume 29, issue 6 h.6.Continued: c50483, c50781 and c9445.If information is provided in the future, a supplemental report will be issued.

Event Description

Endurant stent grafts and non-medtronic stent grafts were implanted in patients for endovascular aortic repair, and 16 patients with late complications after evar underwent open surgical conversion.The following events were reported: serious injury: rupture stent graft infection aortoduodenal fistula hemodynamic instability cardiopulmonary instability cardiac complications pulmonary complications respiratory failure transient ischaemic attack ureter injury subileus death-patient deaths were also reported, however there is no causal link that the endurant device may have caused or contributed to the deaths.

• Brand Name: ENDURANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; IE ; 091708096
• MDR Report Key: 10086258
• MDR Text Key: 193301866
• Report Number: 9612164-2020-01973
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 05/26/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 05/26/2020
• 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): Required Intervention
• Patient Age: 74 YR