MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

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

Patient Problem Stenosis (2263)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient with a history of mild left neck pain for two days, presented with transient right hemiparesis.Mr angiography revealed an intimal flap and intramural hematoma in addition to the cervical ica stenosis.Digital subtraction angiography revealed long irregular stenosis in the left cervical ica, resulting in profound flow restriction.The patient was diagnosed with ica dissection and underwent carotid artery stenting.Under distal filter protection using the non-medtronic device, a non-medtronic 3.0 mm × 20 mm balloon angioplasty was performed.Protégé 8 × 60 mm was deployed to cover the entire lesion.However, prominent stenosis was observed proximal to the stent.Then, the additional stent was placed using protégé 9 × 30 mm, which resulted in good revascularization without neurological deficits.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14758593
• MDR Text Key: 295020120
• Report Number: 2183870-2022-00207
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

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
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/21/2022
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male