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

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Occlusion (1984); Transient Ischemic Attack (2109); Patient Problem/Medical Problem (2688)

Event Date 08/01/2011

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: average age.Sex: majority gender.Event date is literature article published date ¿ only month and year valid overlapped stenting is associated with postoperative hypotension after carotid artery stenting journal of stroke and cerebrovascular diseases (2018) vol.27 no.3 p 653-659 doi: 10.1016/j.Jstrokecerebrovasdis.2017.09.041.If information is provided in the future, a supplemental report will be issued.

Event Description

Between august 2011 and april 2015, 95 consecutive patients with stenosis of the internal carotid artery(ica) underwent 106 carotid artery stenting(cas) procedures without patient selection.All patients received multiple antiplatelet drugs (clopidogrel at 75 mg, aspirin at 100 mg, and cilostazol at 200 mg daily) for at least 1 week before cas.The patients were categorized by the presence or the absence of postoperative hypotension(ht).Demographic data, risk factors, conditions of carotid artery stenosis, procedures, and pre- and intraoperative hemodynamics were compared between these 2 groups.During the procedure, for 10 cases, a guardwire was introduced into the external carotid artery.Under dual protection, pre-dilatation was performed and self-expanding stents were deployed.Medtronic protege rx stents were among those used for these procedures.An export aspiration catheter was placed between the proximal end of the stent and the distal filter and blood aspirated several times from the ica.Subsequently, ivus was performed to confirm the existence of plaque protrusion or migration, and if more than 1 mm of visible tissue was detected on the luminal side of the stent struts, an additional stent was overlapped to cover and compress all of the plaque completely.Transient ischemic attack(tia) occurred in 3 cases overall.Minor stroke was observed in 3 cases of patients who were in the postoperative ht group and these were seen to be resolved completely with 30 days.Plaque protrusion was detected by ivus in 10 cases during cas.All were compressed completely by overlapping an additional stent, which was also confirmed by repetitive ivus.The overlapped stenting was performed with 2 non-medtronic stents in 7 cases, a medtronic protégé and a non-medtronic stent in 1 case, 2 medtronic protégé stents in 1 case, and a medtronic protégé and a non-medtronic stent in 1 case, respectively.Bradycardia was observed, none continued after the procedure.Ae resolved spontaneously with the need for intervention.In total, intra- and postoperative hts were observed in 43 (40.6%) and 30 (28.3%) cases, respectively.Intraoperative ht occurred in 3 cases at predilatation and in 40 at post dilatation.Among the cases with intraoperative ht, 25 were combined with postoperative ht.On the other hand, in 5 cases of postoperative ht, ht arose after cas without history of intraoperative ht.In all cases, ht was treated with etilefrine infusion.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 4600 nathan lane; plymouth MN 55442
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 4600 nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7402014
• MDR Text Key: 104531041
• Report Number: 2183870-2018-00208
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 04/06/2018
• 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: 71 YR