MAUDE Adverse Event Report: 4600N NATHAN LANE PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

Literature: amplitude of tissue oxygenation index change predicts cerebral hyperperfusion syndrome during carotid artery stenting park h.S., nakagawa i., yokoyama s., motoyama y., park y.S., wada t., kichikawa k., nakase h.World neurosurg.2017 99: (548-555) http://dx.Doi.Org/10.1016/j.Wneu.2016.12.062.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A study was carried out between january 2010 and february 2015 to predict cerebral hyperperfusion syndrome during carotid artery stenting by looking at the index change in amplitude of tissue oxygenation.The perioperative amplitude of toi was monitored in 130 patients undergoing cas.The criteria for cas included stenosis >80% for asymptomatic lesions or stenosis >50% for symptomatic lesions, and patients with a high risk for cea in accordance with the stenting and angioplasty with protection in patients at high risk for endarterectomy criteria.One of the devices used for carotid artery stenting was a protege self-expanding stent.In one case of an (b)(6) year old man, hyperperfusion syndrome was observed one day post-procedure with headache and confusion after cas; however, intracranial hemorrhage did not occur because of postoperative sedation using dexmedetomidine and strict systolic blood pressure control immediately after suspicion of hps.As toi laterality (left toi/right toi) recovered 5 days after cas, sedation and strict blood pressure management was terminated.Patient recovered from the symptoms, and then ipsilateral hemisphere rcbf in the resting state demonstrated normalization on the 1-week follow-up.Patient was discharged without any neurological deficits.

Manufacturer Narrative

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

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): 4600N NATHAN LANE; plymouth MN 55442
• Manufacturer (Section G): 4600N NATHAN LANE; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6394415
• MDR Text Key: 69558715
• Report Number: 2183870-2017-00128
• 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,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• 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: 02/09/2017
• 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: 84 YR