MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING BALLOON DILATATION CATHETER; CATHETER, PERCUTANEOUS

Model Number UNK413

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

Patient Problems Hemorrhage, Cerebral (1889); Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

Reference: liu, h., chu, j., zhang, l., liu, c., yan, z., & zhou, s.(2016).Clinical comparison of outcomes of early versus delayed carotid artery stenting for symptomatic cerebral watershed infarction due to stenosis of the proximal internal carotid artery.Biomed research international, 1-7.(b)(6).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same literature article as: (b)(4) (mdr id 2134265-2018-06630), (b)(4) (mdr id 2134265-2018-06632).Reported via journal article within this study.Periprocedural complications occurred, including ipsilateral cerebral hemorrhage and ipsilateral stroke and ipsilateral cerebral hyperfusion, a descent of heart rate or blood pressure and hyperperfusion syndrome occurred.The clinical study results from china aim to compare the clinical outcomes of early versus delayed carotid artery stenting (cas) for symptomatic cerebral watershed infarction (scwi) patients due to stenosis of the proximal internal carotid artery between march 2011 to april 2014.Patients receiving cas within one week of symptom onset were classified in the early cas group and patients receiving cas after 4 weeks from scwi onset were classified in the delayed cas group.A total of 120 patients with symptomatic cerebral watershed infarction due to stenosis of the proximal internal carotid artery treated with cas were included in this study.Of the 120 patients, 63 cases were treated with cas within a week of symptom onset (early cas group) while the remaining 57 cases were treated with cas after 4 weeks from symptom onset (delayed cas group).The mean age of patients in early cas group and delayed cas group was 64.03 plus or minus 3.74 years and 34.12 plus or minus 3.38 years, respectively.For patients in early cas group, daily therapy of aspirin (300¿mg) and of clopidogrel (300 mg) was implemented prior to cas.For patients in delayed cas group, daily therapy of aspirin (100 mg) and of clopidogrel (75 mg) was implemented seven days prior to the cas treatment.Cas was performed under local anesthesia by two experienced neurointerventionists.First, a 8f arterial sheath was punctured into the femoral artery using seldinger technique.A 8f guiding catheter was placed into the common carotid artery at a distance of 3-4¿cm from the stenosis.Second, a filter wire ez system embolic protection device was delivered through the stenotic segment to 4¿6 cm distal to the stenosis and opened.Thirdly, predilation was performed using a sterling monorail 4-5 mm balloon.Fourthly, a wallstent carotid stent system closed-cell stent was positioned in a straight stenotic segment or a non-bsc or wallstent carotid stent system open-cell stent was positioned in a curved stenotic segment.If the stenotic segment was not fully dilated after stent deployment, postdilation was performed using a sterling monorail 4 or 5 mm balloon.Finally, the embolic protection device was removed and punctured femoral artery was sutured.During the periprocedural period, atropine and dopamine were used if patients underwent descent of heart rate or blood pressure.After the procedure, ambulatory blood pressure was monitored for 48 h.Systolic blood pressure was controlled within the level about 80¿90% of preendovascular treatment.After the procedure, all patients received aspirin (100 mg/d) and clopidogrel (75 mg/d) for the first 3 months and aspirin (100 mg/d) thereafter.All patients were advised to come back and see their doctor if there existed cerebral infarction or cerebral hemorrhage after discharge and however come back to the hospital for a check 90 days after discharge from the hospital if there did not exist cerebrovascular disease.All cas was successfully completed in both groups.The technical successful rate was 100%.Two patients (3.2%) in early cas group experienced second stroke presenting with aggravated hemiparalysis during the waiting period of carotid revascularization.Nine (15.8%) patients in delayed cas group experienced second stroke presenting with aggravated neurologic symptoms during the waiting period of carotid revascularization.The rate of second stroke in early cas group is lower when compared to that of delayed cas group (p = 0.032).During the periprocedural period, 51 (81.0%) patients in early cas group and 43 (75.4%) patients in delayed cas group suffered from descent of heart rate or blood pressure (p = 0.464).These patients restored to normal following atropine and dopamine therapy.With regard to the periprocedural complications, there were 3 (4.8%) patients in early cas group and 3 (5.3%) patients in delayed cas group with no statistical significant difference (p = 0.900).Among the three patients in early cas group, one patient suffered from ipsilateral cerebral hemorrhage on the fourth day after cas, which was completely absorbed 2 weeks after cas due to the fact that the hemorrhage volume was less than 5 milliliters.The remaining two patients suffered periprocedural ipsilateral stroke and had poor outcomes in 90 days, while among the three patients in delayed cas group, one patient suffered ipsilateral cerebral hyperperfusion after cas and his symptoms were greatly improved after drug treatment.The remaining two patients suffered periprocedural ipsilateral stroke which aggravated their neurologic symptoms.No death was noted in both groups.No acute cerebrovascular disease was noted in both groups within 90 days of hospital discharge.

• Brand Name: STERLING BALLOON DILATATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7705872
• MDR Text Key: 114547111
• Report Number: 2134265-2018-06631
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K053118
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other