MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

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

Patient Problem Vascular Dissection (3160)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.Initial reporter address 1: (b)(6).Engin, aysen y., and onur saydam."rotational atherectomy with adjunctive balloon angioplasty in calcified chronic total occlusions of superficial femoral artery." vascular 29.5 (2021): 682-692.

Event Description

It was reported via journal article that a dissection occurred.The study aim was to report the mid-term outcomes of jetstream rotational atherectomy device in complex femoropopliteal lesions.Between november 2016 and april 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned.Technical success rate was 100%.The mean age was 63 (plus or minus 10.5) years.The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers.The mean length of the lesions was 20.8 plus or minus 11.2 cm.Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%).Thirty-three (60%) lesions were moderate or severely calcified.Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (poba) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients.After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation.The kaplan - meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively.Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%.No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and poba as an adjunctive therapy, even though primary patency (83.3% vs.61.3%, p equals.06) and secondary patency (91.7% vs.71%, p equals.56) rates of drug-coated balloon angioplasty were slightly higher than poba.Patients with claudication had better primary patency (90.5% vs.58.8%, p equals.001) and secondary patency (100% vs.67.6%, p equals.004) rates than patients with critical limb ischemia at 24 months.Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs.88%, p equals.007) and secondary patency (67% vs.96%, p equals.007).Six patients underwent unplanned amputation.There were eight (14.5%) mortalities during follow-up.

• Brand Name: JETSTREAM ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15527453
• MDR Text Key: 301006897
• Report Number: 2124215-2022-39095
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• 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: 09/07/2022
• 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): Required Intervention