MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON; CATHETER, PERCUTANEOUS

Model Number REL46

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

Patient Problems Death (1802); Vascular Dissection (3160)

Event Date 06/12/2017

Event Type  Death  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant stent graft system was implanted in a patient for the endovascular treatment of a chronic type b dissection that has turned into a 6.3 cm in diameter thoracic aortic aneurysm.The physician elected to perform a right carotid to left carotid to left subclavian artery bypass, embolization of the lsa, and ligation of the lcca prior to insertion of the valiant stent graft.It was reported that there were difficulties advancing the valiant stent graft to the intended landing zone due to the patient¿s severely tortuous aorta and tightness of the thoracic aorta arch.During the deployment of the valiant device, the nose cone caught on another manufacturer¿s occlusion device in the lsa and dislodged it into the ascending thoracic aorta.The occlusion device made it up into the thoracic arch, where the physician deployed the valiant stent graft capturing the occlusive device between the valiant stent graft and the vessel wall.The valiant stent graft was completely deployed landing the proximal end distal the innominate artery.During the recapture of the nose cone, the nose cone would not go through the valiant stent graft due to the tightness and angle of thoracic arch.The physician inserted a reliant balloon to the opposite side to balloon the valiant stent graft open.After several manipulations, the nose cone was retrieved and valiant delivery system was pulled out of stent graft into the abdominal aorta.The physician decided to balloon the proximal portion of valiant stent graft and the steep arch segment since the reliant balloon was already there.After ballooning that section of stent graft, the patient lost blood pressure and cpr was initiated.A tee probe was inserted there was a retrograde type a dissection.After 20 minutes of cpr and medication were administrated, there were no changes nor patient response, the cpr was ceased and the patient expired.Per the physician, the causes of the events were related to the patient¿s anatomy; severely tortuous aorta, tightness of the thoracic aorta arch and retrograde type a dissection.The cause of the retrograde type a dissection is unknown but may be related to the removal difficulties or the reliant balloon inflation in conjunction with the patient unfavorable anatomy.No additional clinical sequelae were reported.

Manufacturer Narrative

Film evaluation summary review of pre-implant cta¿s revealed that the patient had a type b aortic dissection in the descending aorta.The proximal segment of the descending aorta was aneurysmal, with max diameter measured ~ 6.5 cm.The aorta at the level of the left carotid artery measured ~ 34 mm in diameter.The aortic arch was just caudal to the lsa, and the aortic arch was steeply angulated, ~ 150 deg.The dissection originated at the left subclavian artery and extended down to just below the lowest left renal artery.The true lumen diameter was extremely small, ranged from ~ 8 mm to ~ 10 mm from proximal to distal.The false lumen diameter ranged from ~ 5 cm to ~ 2.5 cm from proximal to distal.The descending aorta was severely tortuous (s-shaped).The celiac, sma, and renals came off from the true lumen.The infrarenal aorta and left iliac arteries were severely tortuous.The right iliac arteries were mildly angulated.The external iliac arteries diameter measured ~ 7 mm.The exact cause of events could not be conclusively determined from the pre-implant cta¿s provided.Films at the index procedure that showed the events were not provided for review, therefore the reported events could not be confirmed.The pre-implant cta¿s showed that the patient had a very challenging anatomy; the aortic arch was steeply angulated and the descending aorta was severely tortuous (s-shaped).The true lumen diameter was extremely small, ranged from ~ 8-10 mm.It is possible that patient¿s challenging anatomy may have contributed to the events.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6688471
• MDR Text Key: 79115900
• Report Number: 2953200-2017-01077
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050038
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death; Required Intervention
• Patient Age: 63 YR