MAUDE Adverse Event Report: PLYMOUTH-PA PROTEGE RX; STENT, CAROTID

Model Number SECX-10-7-40-135

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.(b)(4).

Event Description

It is reported that the protege rx was placed in the subclavian artery.During a routine 1 week follow up the physician found that the protege rx was partially kinked through ct imaging.There is no reported patient injury.

• Brand Name: PROTEGE RX
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): PLYMOUTH-PA; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): PLYMOUTH-PA; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5164988
• MDR Text Key: 29095248
• Report Number: 2183870-2015-00406
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SECX-10-7-40-135
• Device Catalogue Number: SECX-10-7-40-135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR