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

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

Patient Problem Extravasation (1842)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date article published online journal article title: percutaneous mechanical thromboembolectomy in acute lower limb ischemia cardiovasc intervent radiol (2019) 42:178¿185.Https://doi.Org/10.1007/s00270-018-2129-3.If information is provided in the future, a supplemental report will be issued.

Event Description

A (b)(6) male patient with acute onset of calf pain 6 weeks earlier and very short walking distance.Clinical stage rutherford i.A 6-week-old embolus riding on the trifurcation with occlusion of both anterior tibial orifice as the proximal tibioperoneal trunk.Rotational thrombectomy appeared risky due to the curved and small anatomy.The orifice of the anterior tibial artery could be successfully reopened by use of an atherectomy catheter (silverhawk, medtronic) but after atherectomy of the tibioperoneal trunk, extravasation is visible.After prolonged balloon angioplasty, the leakage was sealed and patency restored.

• 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: 8393644
• MDR Text Key: 137929507
• Report Number: 9612164-2019-00786
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• 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: 02/25/2019
• 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: 55 YR