MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK BTK; CATHETER, PERIPHERAL, ATHERECTOMY

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

Patient Problems Embolism (1829); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Occlusion (1984); Sepsis (2067); Perforation of Vessels (2135); Patient Problem/Medical Problem (2688)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The purpose of this article is to analyze the immediate outcome of percutaneous mechanical thromboembolectomy in acute infrainguinal leg ischemia in a consecutive cohort of patients with acute lower limb ischemia.It retrospectively analyzes 156 treatments (148 patient¿s) for lower limb ischemia by mechanical thrombectomy within a 10-year period.Besides very few exemptions, an intervention was started by aspiration first but if aspiration failed to remove significant amounts of clot even by repeat aspiration runs or increased catheter diameter, an additional device was added.Most frequently, a rotational thrombectomy device was used.In rare instances, other devices such as stents, stent grafts or atherectomy catheters were added directional atherectomy (silver hawk or turbohawk, medtronic) was applied in localized wall-adherent clot material mainly in small arteries or in curved locations.Peri-interventionally, 5000 iu of intraarterial heparin were added.Post-treatment anticoagulation protocol included i.V.Heparinization for at least 72 h while searching for embolic sources and cardiac arrhythmia.In cases with embolism, an oral anticoagulation regimen was started in an overlapping fashion; in patients with thrombotic events, a double-platelet regimen was started for at least 3 months.A technical success was defined if complete thrombus removal from the main axis and at least one crural artery patent down to the foot arteries or to sufficient pre-existing collaterals to the foot arteries was achieved.Clinical success was defined as the absence of clinical symptoms of acute ischemia with limb salvage at the date of hospital discharge.In 145 of 156 incidents, a technical success was achieved (93%) with at least one patent crural artery or sufficient collateral flow to the foot arteries.In 11 incidents (7%), the treatment failed to achieve the definition of technical success.But in four of them, at least partial success was obtained.Failure rate was higher for thrombotic (three cases, 9%) and thromboembolic (two cases; 11%) than for embolic events (6%).With regard to the outflow status, the intervention remained technically insufficient in seven patients with no patent outflow vessel, in two patients with one outflow vessel and in two patients with two patent outflow vessels but remaining distal arterial occlusion.Aspiration was used in 153 incidents (98%).Rotational thrombectomy was added in 60 cases (38%).Directional atherectomy was applied in a total of five patients (3.2%) with occlusion type 3 in 4 patients and type 2 in one patient.Atherectomy only was used in one patient and combined with other methods in four incidents.Technically, all five cases were successful.There were a number of acute complications.Most frequently, a downward embolization, and one upward embolization occurred.Further aspiration was successful to clear this complication but remained unsuccessful in 4 cases.In two incidents, severe arterial spasm of the crural arteries occurred but remained without clinical sequelae.Arterial perforation occurred in two cases, one due to rotational thrombectomy and one due to directional atherectomy.Prolonged balloon dilatation was sufficient to seal the vessel in both cases.In five cases, the patients suffered from limited severe hypotension that required termination of the procedure.In one patient, the intervention had to be terminated due to severe ischemic pain.In one patient, the closure system could not be delivered properly leading to development of a severe groin hematoma that required immediate surgical revision.There were three additional hematomas that required surgical revision.In two cases, a larger hematoma was treated conservatively.Clinically, 86.5% showed a profound improvement of their clinical situation with the absence of clinical signs of acute ischemia.Partial minor amputation (toe, foot) was performed in four cases following thrombectomy but with no further signs of acute ischemia.Early reocclusion despite primary technical success occurred in four cases.Surgical bypass was performed in three patients but failed early in one.Surgical thrombectomy was further applied in two patients.Five patients underwent amputation of the ipsilateral thigh.Five patients underwent conservative treatment.Three patients developed lower leg compartment syndrome despite successful thrombectomy (1.9%) requiring surgical intervention.Five patients (3.2%) died within the early phase \30 days post-intervention.Two patients died suddenly for unknown reasons, no autopsy was performed.Two patients died from their underlying disease (bronchial and breast carcinoma) and one patient died from septic complications of a gangrenous limb after failed recanalization.Most of the patients were dismissed from hospital without clinical signs of acute ischemia.Three patients were handicapped by the sequelae of a synchronous stroke.In the follow-up period, seven patients experienced a recurrent embolization to the lower limbs.Five patients experienced a stroke (at 6 weeks, 3, 6, 11 and 36 months), and in two patients, it was fatal.One patient experienced a fatal mesenteric infarction 24 months after peripheral embolectomy.One patient died from pneumonia 7 months and one patient from cardiac insufficiency 4 months later.One patient became symptomatic from an ipsilateral popliteal arterial stenosis within 12 months after thrombectomy that was treated percutaneously.

• Brand Name: SILVERHAWK BTK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8390770
• MDR Text Key: 137837962
• Report Number: 9612164-2019-00780
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR