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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vasoconstriction (2126); Vascular Dissection (3160)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
(b)(6) study. It was reported that occlusion, recoil, and dissection occurred. On (b)(6) 2018, a 7mm x 120mm (b)(6) study stent was deployed to treat a target lesion in the right mid superficial femoral artery. The target lesion was located in right mid superficial femoral artery (sfa) with 99% stenosis and was 100 mm long. The lesion had a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6mm. The target lesion was predilated and a 7 mm x 120 mm study stent was implanted. Post dilation revealed 0% residual stenosis. The patient was discharged two days later on antiplatelet therapy. On (b)(6) 2020, the patient presented with complaints that the current walking distance was deteriorated by approximately 50 meters, and additionally caused pulling and pain in the right calf, which improved at rest. The patient underwent angiography, which revealed long stretch, higher grade in stent restenosis at the target lesion in the study stent. It was also noted that proximal and distal portion of the stented segment had high grade, in places subtotal, stenoses through to the femoropoplieal junction. An areterial doppler occlusion pressures revealed ankle-brachial index (abi) at right was 0. 3 and left was at 0. 6 a duplex ultrasound examination at the superficial femoral artery revealed perfused outflow, extremely calcified, then with turbulent flow, and no further perfusion before the stent already through to the distal popliteal artery. On the same day, the patient was hospitalized for further treatment and evaluation. On (b)(6) 2020, size 14 and size 18 non-boston scientific wires were passed through the femoral lesion and passed through the popliteal region with dilation using a 5mm x 120mm sterling balloon, and advance dilation with a 5mm x 40mm ranger balloon followed by long stretch, two 6mm x 150 mm ranger drug coated balloon angioplasty. Due to recoil and dissection post angioplasty with the sterling and ranger balloons, treatment was completed with different devices. On (b)(6) 2020, an arterial doppler occlusion pressures revealed abi at right was 0. 7 and left was at 0. 7. A duplex ultrasound showed no relevant residual stenosis in sfa and strong flow to the popliteal region. The event was considered to be recovered and resolved. The patient was discharged on the same day in a good general state.
 
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Brand NameSTERLING
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10683387
MDR Text Key211464816
Report Number2134265-2020-13801
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K132430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/18/2021
Device Model Number24715
Device Catalogue Number24715
Device Lot Number0025532112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/15/2020 Patient Sequence Number: 1
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