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

Model Number ETBF3616C166EE

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

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Death (1802); Embolism (1829); Headache (1880); Unspecified Infection (1930); Pain (1994); Pleural Effusion (2010); Pneumonia (2011); Swelling (2091); Respiratory Failure (2484)

Event Date 10/16/2018

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id; unk-cv-sr-endur-ii, s/n: unknown; use by date: unknown; upn # unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii(s) stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that the patient was hospitalized and the next day was diagnosed with cerebellar infarction.The cause of the event is unknown.No additional clinical sequelae were reported, and the patient will be monitored.

Manufacturer Narrative

Additional information was received: the patient was admitted to a neurosurgical unit where a craniotomy and ventricular drainage was performed.The investigator has assessed as the event as unlikely related to the endurant and renal device and possibly related to the procedure.The sponsor has assessed the event as not related to the endurant or renal device and as having a causal relationship to the procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Fdc code added at investigation completion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

The investigator was determined the death was not device related.

Manufacturer Narrative

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

Event Description

The patient also had a vp shunt implanted on (b)(6) 2018 and a tracheotomy carried out on (b)(6) 2018.The investigator has assessed the death to be unlikely to be related to the endurant device or procedure.The date of death was approximately seven months post the index procedure and occurred due to the patients reported complications.The cerebellar infarction was diagnosed the day after the index procedure and lead to the cerebellar hemorrhage and cerebral edema.The respiratory failure occurred one week post the index procedure.It was reported that the patient was unable to be extubated leading to re-intubation, pneumonia, tracheotomy, long term ventilation and a pulmonary embolism.The investigator has accessed the respiratory failure to be unlikely related to be related to the endurant device or procedure and it was noted there would not have been complications without the chevar procedure.

Manufacturer Narrative

Additional information received: it was reported that the event would not have occurred if the evar procedure had not been carried out, however its relationship to the endurant iis system was unlikely.The craniotomy that was carried out led to an occipital wound healing complication, an arterial lung emboli, and a vancomycin resistant enterococcus infection.Medtronic if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received: in addition to the previously reported cerebellar infarction, the following were also noted within 30 days of the index procedure; small infarct demarcation in the right occipital region, frontal edema / intracerebral hemorrhage, swelling of the paranasal sinuses, right pulmonary embolism, respiratory failure, suspected pneumonia, mild pleural effusions, trigeminal neuralgia and migraine.It was also reported that the patient died, more than 30 days post index procedure.The patient death was assessed by the investigator as not related to the index procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was reported the patient experienced vre infection on (b)(6) 2018, the event reported to be possibly related to the procedure as per the sponsor but not related to device or procedure per the investigator.The respiratory failure relatedness assessment was updated to causally related to the procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: it was reported the vancomycin resistant enterococcal (vre) infection resolved 4 months later.The sponsor has assessed the death as not related to the procedure or to the device and the site has updated its event relationship assessment to unlikely to be related to the procedure or to the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received; the cerebellar infarction was assessed as unlikely related to the device but possibly related to the procedure as per the site, and causally related to the procedure per the sponsor.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8027362
• MDR Text Key: 125745301
• Report Number: 2953200-2018-01523
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/14/2021

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 Expiration Date: 09/26/2020
• Device Model Number: ETBF3616C166EE
• Device Catalogue Number: ETBF3616C166EE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 12/04/2018; 01/10/2019; 03/27/2019; 05/24/2019; 06/21/2019; 07/19/2019; 11/16/2020; 02/03/2021; 03/18/2021
• Supplement Dates FDA Received: 12/19/2018; 01/10/2019; 04/23/2019; 06/19/2019; 07/18/2019; 08/12/2019; 12/10/2020; 03/01/2021; 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 76 YR