MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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

Patient Problems Death (1802); Ischemia (1942)

Event Date 10/21/2016

Event Type  Death  

Manufacturer Narrative

Literature reference: dx.Doi.Org/10.1016/j.Wneu.2016.1064.If information is provided in the future, a supplemental report will be issued.

Event Description

From journal article: the safety and efficacy of noncompliant balloon angioplasty was reported for treatment of subarachnoid haemorrhage-induced cerebral vasospasm at three major academic institutions in the united states.Vessels treated include the internal carotid artery (ica), middle cerebral artery (mca), anterior cerebral artery (aca), basilar artery (ba), posterior cerebral artery (pca), posterior inferior cerebellar artery (pica) and vertebral artery (va).Aneurysmal subarachnoid haemorrhage (sah) was present in 50 patients, whereas the sah was from an unknown source in 2 patients.The sprinter legend balloon was the most commonly used balloon during the angioplasty procedures.During the procedure, the balloon was inflated to nominal pressure at a rate of 2-4 atm per minute using a manual insufflation device and repositioned after deflation as needed.All procedures used noncompliant balloons.The mca and intracranial ica were the most commonly treated vessels.No procedure related complications were reported.There was improvement in angiographic vasospasm in 97% of cases without any associated procedural morbidity or mortality.Outcome included delayed cerebral ischemia.Functional outcome after discharge from icu included patient death.One patient presented with a ruptured anterior choroidal internal carotid artery aneurysm, which was subsequently treated with endovascular embolization.The procedure was complicated by thrombosis of the right anterior cerebral and middle cerebral arteries, which was treated with medical thrombolysis and mechanical thrombectomy.The patient developed significant cerebral edema of the right hemisphere and underwent hemicraniectomy.On hospital day 4, the patient had a decline in mental status and was taken for digital subtraction angiography.Angiographic vasospasm was found in the right m1 segment of the middle cerebral artery and right a1 segment of the anterior cerebral artery.Angioplasty was performed with a sprinter legend balloon (1.5 mm x 10 mm) in the right m1 segment, and intra-arterial verapamil was infused in both right m1 and a1 segments.Vasospasm of the right m1 segment improved from severe to moderate.The patient¿s clinical condition remained poor, and the patient died on hospital day 10.

Manufacturer Narrative

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.

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7343533
• MDR Text Key: 102569192
• Report Number: 9612164-2018-00519
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 02/16/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 07/19/2018; 08/08/2018
• Supplement Dates FDA Received: 07/19/2018; 10/04/2018
• 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
• Patient Age: 59 YR