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

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: a single-center experience of endovascular treatment in subtypes of basilar artery occlusion: embolization caused by tandem vertebral artery stenosis may be associated with better outcomes authors: lin jiang, jian-hong yang, jie ruan journal: world neurosurgery year: 2021. Reference: doi. Org/10. 1016/j. Wneu. 2021. 05. 011. Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s). Was provided average age, majority gender, date of publication. If information is provided in the future, a supplemental report will be issued.

Event Description

An article titled - a single-center experience of endovascular treatment in subtypes of basilar artery occlusion: embolization caused by tandem vertebral artery stenosis may be associated with better outcomes - was submitted. The aim of the study was to compare the surgical procedures and clinical outcomes of mechanical thrombectomy in different subtypes of basilar artery occlusion (bao). Eighty-six patients with acute bao receiving endovascular treatment between october 2015 and july 2019 were retrospectively analyzed and placed in 3 groups: pure embolism (group 1), arterial-arterial embolism from steno-occlusion of the tandem vertebral artery (group 2), and in situ atherosclerotic thrombosis (group 3). Recanalization rates, procedure times, surgical characteristics, and clinical outcomes were analyzed. Rescue treatment was performed by switching to the stent retriever or aspiration, balloon angioplasty, permanent stent placement, intra-arterial glycoprotein iib/iiia antagonist, or any combination of these. Three patients had a balloon angioplasty. Balloon angioplasty was carried out with either a medtronic sprinter legend balloon or a n on-medtronic balloon. Clinical outcomes among the three basilar artery occlusion subtypes included intra-arterial tirofiban, modified thrombolysis in cerebral infarction (mtici) grade 2b or 3, mortality at 90 days, any hemorrhagic complication, symptomatic intracerebral hemorrhage and parenchymal hemorrhage type 2.

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• 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 ; EI ; 091708734
• MDR Report Key: 12959440
• MDR Text Key: 285344759
• Report Number: 9612164-2021-04758
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No