MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; CATHETER, CONTINUOUS FLUSH

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

Patient Problem Embolism/Embolus (4438)

Event Date 12/23/2021

Event Type  Injury  

Event Description

It was reported that an embolism occurred.The target lesion was located in the superficial femoral artery (sfa).Angiography shows an occlusion of the sfa 1 cm beyond origin with reconstitution at the first portion of the popliteal.Recanalization was performed without difficulty.Two 6x120,130cm eluvia drug-eluting vascular stent system and one 6x100,130cm eluvia drug-eluting vascular stent system were implanted in the sfa on (b)(6) 2021.Revision angiography 1 month post-index procedure prior to revascularization of the contralateral limb showed patent eluvia stents without apparent issues and good flow to the foot.On (b)(6) 2021, the patient presented with pain and a cold leg, arriving to the hospital with partial sensory an motor loss, indicating an advanced degree of ischemia.The patient was never compliant with antiplatelet medication.Angiography showed occlusion of the stents which, in the most proximal part were jailing the profunda femoris, causing an occlusion of this vessel, complicating the ischemic status of the limb.Ekos was used overnight for thrombolysis but ischemia was so advanced at the time of presentation that the patient developed a distal embolization and compartment syndrome after revascularization.A consultation with orthopedic surgery resulted in a "wait and see" and a posterior decision of above-the-knee amputation.Fasciotomy was not performed.The angiography post-ekos revealed an unusual image with a "string of beads" appearance along the stented segment, similar to that encountered in fmd (fibromuscular dysplasia), alternating stenotic and aneurysmatic segments.The physician will run tests to check for giant cell arteritis or other arterial inflammatory or generative diseases.

• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13508306
• MDR Text Key: 286751348
• Report Number: 2134265-2022-01284
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male