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

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

Patient Problems Myocardial Infarction (1969); Perforation (2001); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Title: comparison and analysis between the nav6 embolic protection filter and spiderfx epd filter in superficial femoral artery lesions author: prakash krishnan, arthur tarricone, allen gee journal: journal of interventional cardiology year: 2021 vol/issue: 2021 ref: doi.Org/10.1155/2021/9047596.Journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to compare the safety and efficacy between the spider fx embolic protection device and a non-medtronic filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with pad.Medtronic¿s spider fx embolic protection devices ( and silverhawk atherectomy devices were used in the study.507 patients with lower peripheral artery disease were treated with atherectomy and epd.Of these 346 patients were treated with the spider fx epd.Treatments were in the superficial femoral artery (sfa), with the exception of 2 in the femoropopliteal artery for each treatment group.The frequency of pre-procedure in-stent restenosis was 6.8% in the non-medtronic filter treated patients and 8.1% in the spider fx group.The majority of patients were treated with the silverhawk directional atherectomy (362 patient¿s), with the remainder of treatment roughly equally between rotational atherectomy and laser atherectomy.Access complications were related to closure devices and not related to filter therapy or treatment and were reported in 2 patients in the spider fx group.Recoil was related to balloon treatment and was reported in 4 patients in the non-medtronic filter group.Filter overflow in the spider fx group defined as macroscopic debris filling the entire filter with no flow through the filter after intervention was reported in close to 64% of spider fx filters.In the spider fx group, events which contributed to the mae rate include death, mi, thrombosis, dissections, and distal embolisation.10 cases of mi were reported in the spider fx group of which there was no date provided for occurrence of 9 of these, thrombosis occurred 4 patients receiving spider fx filters, all but 1 of which occurred on the day of the procedure.1 occurred 1-week post procedure with tvr.Another event of tvr occurred in a spider fx epd patient and was reported approximately a month later.Dissection occurred in 10 spider fx cases.Dissection is typically a complication related to angioplasty balloon expansion and is not a complication typically associated with epd.The cause of deaths were unknown.There is no established or suspected causal relationship between the device(s) and the death events.

• Brand Name: SILVERHAWK BTK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12246184
• MDR Text Key: 264087991
• Report Number: 9612164-2021-02944
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: 07/15/2021
• 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: 69 YR