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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Sepsis (2067); Arteriosclerosis/ Atherosclerosis (4437)
Event Date 08/25/2021
Event Type  Injury  
Event Description
(b)(6) trial it was reported that atherosclerosis, gangrene and sepsis occurred. The subject underwent treatment with the ranger drug coated balloon in (b)(6) 2021 as a part of the (b)(6) trial. The target lesion #001 was in the left common femoral artery, proximal superficial femoral artery (sfa), mid sfa extending to distal sfa with unknown proximal reference vessel diameter and distal reference vessel diameter of 5. 0 mm with lesion length of 300 mm and 100 % stenosis and was classified as tasc ii d lesion. Pre-dilatation in the target lesion was performed with 5 mm x 150 mm sterling balloon. Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon. Following post treatment, the final residual stenosis was noted to be 10%. The target lesion #002 was in the left proximal popliteal artery, mid popliteal artery extending to distal popliteal artery with proximal reference vessel diameter of 0. 0 mm and distal reference vessel diameter of 5 mm with lesion length of 300 mm and 100 % stenosis. Pre-dilatation in the target lesion was performed with 5 mm x 150 mm sterling balloon. Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon. Following post treatment, the final residual stenosis was noted to be 10%. In (b)(6) 2021, the subject was discharged from the hospital. Three days post hospital discharge, the subject was noted with worsening of peripheral arterial disease. In (b)(6) 2021, the subject visited the emergency department of hospital due to increasing left foot pain for the past 2 weeks and bilateral leg swelling with weeping of bilateral lower extremities. Left foot pain was non-radiating and associated with increased blistering of prior left foot wound. On evaluation, the subject was noted with concerns of left lower extremity cellulitis and possibility of sepsis. The left leg wound was circumferentially 3 cm that was wet with surrounding erythema and bluish coloration of the toes. The subject had extensive gangrene involving forefoot and midfoot. The subject had necrotic heel ulceration on the lateral aspect approximately 5 cm in size and blistering of calf. The left foot was cold with cap refill of 3 seconds and the first two toes were blue and mottled and had decreased sensation in the bilateral lower feet to ankle and decreased motor strength in the left leg than in the right. Abi index performed revealed 1. 08 in the right and 0. 57 in the left indicating severely dampened at the left calf and ankle. Blood culture was obtained, and the subject was started on broad spectrum antibiotics in response to the concerns for lower extremity cellulitis and possibility of sepsis. The subject also had confusion and decreased concentration. The subject did not have history of recent falls concerning for fracture and sprain. Leukocytosis, tachycardia and altered mental status were all concerning for systemic inflammatory response syndrome (sirs)/sepsis. Based on the findings, the subject was hospitalized for further management and recommended for left guillotine through ankle amputation on the same day. On the same day, left guillotine through the ankle amputation was performed. Hemostasis was achieved in the wound and the leg was dressed with kerlix and an ace wrap. The subject was transported to medical intensive care unit in critical condition. The subject was advised to be on pneumatic compression stockings and to continue on anticoagulation therapy for vte prophylaxis. The next day, the subject activity involved mobilization. Four days later, the subject continued to have tenderness and calf pain in the left lower limb. On evaluation, the left guillotine amputation site was noted with ischemic tissue at the stump with no purulence and no erythema of skin. The following day, the subject was noted with worsening leukocytosis and tenderness in the left calf concerning of spread of ascending infection (left lower leg infection). The subject was noted with ischemic tissue on the stump. The subject was then recommended for left guillotine through knee amputation since the pvr waveform might not be amenable for below knee amputation. Left guillotine amputation was performed at the knee joint. Hemostasis was achieved in the wound. The leg was then dressed with kerlex, abd and an ace wrap. The subject was then transferred to post anesthesia care unit (pacu) in stable condition. The subject was stable overnight and had been on nothing by mouth (npo). The subject was given a sedater due to pulling lines. Two days later, the subject had subsequent ascending infection in the left lower leg. Above knee amputation was performed. The femur was identified and cleared using the periosteal elevator and a sponge. An oscillating device was then used to divide the bone and the remainder of the above knee amputation was completed with an amputation knife. Hemostasis was achieved within the wound. The superficial femoral artery, femoral vein and sciatic nerve were all ligated independently. The wound was irrigated with antibiotic solution. The leg was dressed with xeroform, kerlix, abd pad and an ace wrap. The subject was then taken to recovery in stable condition. Seven days later, the subject was evaluated and noted to be afebrile and had no leukocytosis and pain was controlled. No erythema noted at the left above the knee amputation site. Two days later, in (b)(6) 2021, the subject was discharged from the hospital.
 
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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)
HEMOTEQ AG
adenauerstrasse 15
wurselen 52146
GM 52146
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12619235
MDR Text Key276383670
Report Number2134265-2021-12754
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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