MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM; STENT, CORONARY

Model Number UNK679

Device Problem Partial Blockage (1065)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Reference: akkan, k., iigit, e., onal, b., cindil, e., solak, e.P., oncu, f., & geylan, d.E.(2018).Endovascular treatment for near occlusion of the internal crotid artery.Clin neuroradiol, 245-252.(b)(4).

Event Description

Same literature article as: (b)(4) (mdr id 2134265-2018-06686).(b)(4) (mdr id 2134265-2018-06712).(b)(4) (mdr id 2134265-2018-06723).Reported via journal article that within this study, minor stroke occurred during the procedure.Stent restenosis occurred post procedure.30 day outcome of myocardial infarction was reported.Clinical study results from turkey aim to report perioperative and long-term follow-up results of internal carotid artery (ica) near occlusion (no) patients that were treated with carotid artery stenting (cas) between the years of 2004 and 2014.One-hundred eighty-two (182) patients were selected for the study after numerous preprocedural examinations by the treatment team.The statistics from the procedures and follow up are as follows.The unspecified filter device could not be advanced through the stenosis in 72 patients.In these patients predilatation without distal protection was performed with a 3 mm ultrasoft bsc balloon catheter.Subsequent filter device (unspecified) delivery attempts were successful in all cases.In the remaining 110 patients the embolic protection device was successfully delivered distal to the stenotic segment and predilatation with a 3 mm ultrasoft bsc balloon catheter was performed before stenting in each case.For distal protection a filter wire ez was used in 42 patients and a non-bsc filter was used in 140 patients.Then for stenting, a non-bsc stent was used for 14 patients, a wallstent bsc stent was used in 85 patients, and another non-bsc stent was used in 83 patients.Post dilatation was performed with 5-6 mm ultrasoft bsc balloon catheters for all patients.All procedures were performed with the patients under local anesthesia with continuous invasive arterial blood pressure and electrocardiographic monitoring.A percutaneous transfemoral approach was used for cas in all cases via a non-bsc introducer sheath placed in the distal common carotid artery.Stented segment, ica and ipsilateral intracranial vasculature were angiographically evaluated in each case following the intervention via the sheath in the common carotid artery.After the stenting procedure all patients remained in the neurological intensive care unit for at least 12 hours under 750 units intravenous heparin infusion per hour with activated partial thromboplastin time monitoring.The follow-up protocol included neurological evaluation and carotid doppler ultrasound (dus) on day 1 as well as after 1, 3 and 6 months and 1 year after the intervention and each year thereafter.Temporary hemodynamic changes, such as bradycardia in 108 patients, hypotension in 55 patients, and asystole in 19 patients occurred during post dilatation and were managed with intravenous 1 mg atropine in all cases.After predilatation, intimal dissection was seen in 29 patients and treated with stenting.The angiography after stent deployment and post dilatation showed filter (unspecified device) occlusion in 8 patients.No remarkable difficulties were encountered during filter removal in any case.No major vascular complications related to the intervention were recorded.Of the patients 4 developed minor ipsilateral stroke.These patients had already established small ischemic areas on the ipsilateral hemisphere before the cas procedure and the early mri showed the increased number of small areas after the treatment.The 30 day outcome revealed a "dsmi rate of 1.1%," 2 patients developed myocardial infarction shortly after the cas procedure but no major stroke or death occurred in the 30-day follow-up.One patient stopped taking dual antiplatelet medication after discharge from hospital and developed an ipsilateral major stroke 45 days after the procedure.The stroke was most probably related to the problem of the ica.The median clinical and carotid dus follow-up period was 64 months (range 18-124 months).Restenosis was determined by carotid dus in the 3-month follow-up in 1 patient and after 1-year follow-up in 6 patients.In these 7 cases, 4 patients were treated with wallstent bsc stent and the other 3 cases were treated with non-bsc stents; stenting/post dilatation stages of the intervention were under filter protection in all cases.Selective catheter angiography showed restenosis rates between 50-70% in these patients and they were retreated with percutaneous transluminal angioplasty (pta) after the clinical evaluation of the neurologist.During the follow-up period 21 patients died, 12 from vascular causes (8 myocardial infarctions and 4 pulmonary embolism) and 9 from nonvascular diseases.

• Brand Name: WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7678993
• MDR Text Key: 113705043
• Report Number: 2134265-2018-06711
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• PMA/PMN Number: P980033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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