MAUDE Adverse Event Report: MEDTRONIC IRELAND ATK TURBOHAWK CALCIUM; CATHETER, PERIPHERAL, ATHERECTOMY

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

Patient Problems Perforation (2001); Obstruction/Occlusion (2422); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

Title: critical appraisal of the contemporary use of atherectomy to treat femoro popliteal atherosclerotic disease author: ryan gupta, sammy siada, samuel lai journal: journal of vascular surgery year: 2022 vol/issue: 75(2) ref: 10.1016/j.Jvs.2021.07.Average age, majority gender, date of publication 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 review article was submitted presenting a systematic review and meta-analysis to investigate the outcomes and complications related to atherectomy to treat femoropopliteal atherosclerotic disease.Twenty-four studies encompassing 1900 patients met the inclusion criteria for the present study.Of the 1900 patients, 74.3% had presented with rutherford class 1 to 3 and 25.7% presented with rutherford class 4 to 6; 1445 patients had undergone atherectomy, and 455 patients had been treated without atherectomy.The atherectomy group had undergone directional atherectomy (n = 851), rotational atherectomy (n = 851), laser atherectomy (n = 201), and orbital atherectomy (n = 78).Most of these patients had also received adjunct treatments, which varied across the studies and included a combination of stenting, balloon angioplasty, or drug-coated balloon angioplasty.Within the 24 studies reviewed, medtronic¿s silverhawk and turbohawk devices were identified as directional atherectomy devices used.Technical success was achieved in 92.3% of the cases.Distal embolization, vessel perforation, and dissection occurred in 3.4%, 1.9%, and 4% of the cases, respectively.The initial patency was 95.4%.At the 12-month median follow-up, the primary patency was 72.6%.The ankle brachial index had improved from a preoperative mean of 0.6 to a postoperative mean of 0.84.The incidence of major amputation and mortality during the follow-up period was 2.2% and 3.4%, respectively.There is no established or suspected causal relationship between the device(s) and the death events.

• Brand Name: ATK TURBOHAWK CALCIUM
• 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: 13507404
• MDR Text Key: 286952753
• Report Number: 9612164-2022-00568
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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: 02/07/2022
• 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): Hospitalization