MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; CORONARY DRUG-ELUTING STENT

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

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Hematoma (1884); Perforation of Vessels (2135)

Event Date 03/28/2022

Event Type  Injury  

Event Description

Same case as pr id #: (b)(6).Champion-af study.It was reported vessel perforation occurred; the patient experienced atrial fibrillation, atrial flutter and hematoma requiring intervention.In (b)(6) 2022, the subject was diagnosed with coronary artery disease and referred for cardiac catheterization procedure which revealed stenosis in left circumflex (lcx) artery and right coronary artery (rca) lesions.In (b)(6) 2022, subject underwent percutaneous coronary intervention (pci) and two drug eluting stent was placed at lcx artery and another pci for right coronary artery rca lesion was scheduled.On the following day, the event was considered to be resolved and the subject was discharged on 81mg aspirin.Eighteen days later, the subject presented for scheduled pci at distal rca.During the procedure, pre-dilation was performed with 2.5 x 20 mm emerge balloon catheter in the distal right coronary which resulted in large plane of dissection extending both proximally and distally from the mid-to-distal vessel and at this point flow began to get compromised.Subsequently, subject developed bradycardia, heart block and started to decompensate slightly.The dissection in the right could had been from guide trauma but it really did start after balloon inflation, there was one shot that showed guide sitting deeply into the right coronary with the dissection plane extending all the way to segment.Immediately, the subject was treated at the ostial segment with a 3.0 x 38 mm promus elite stent.Subsequently, the physician deployed a 2.5 x 38 mm promus elite stent into the distal rca.Given the extent of the dissection and compromised flow, subject was deployed 2.25 x 32 mm promus elite stent and 3.0 x 24 mm promus elite stent in the mid vessel overlapping with previously placed stents creating a "full metal jacket".The subject was successfully deployed three stents with brisk antegrade timi flow, however parting angiographic shots revealed there was evidence of a small perforation with dye extravasation into the aorta.Intravascular ultrasound (ivus) evaluation of right coronary demonstrated by non-boston scientific (bsc) covered stents was placed into the diseased segment with successful tamponade of the extravasation.The complaint has been submitted for the small perforation in rca.Furthermore, there was still evidence of a small micro perforation in the posterior descending artery (pda) for which balloon tamponade of 2.0 x 15 mm apex balloon catheter was used for 10 minutes at distal pda to occlude perforation.The subject was monitored closely for hemodynamic stability and was admitted to intensive care unit (icu) for close monitoring.Right groin was dry and intact and there were no immediate complications during the procedure.On monitor, the subject was in atrial fibrillation or atrial flutter within range of 48-62, systolic bp was 80s-100s.On the same day, due to concern of possible aortic dissection, computed tomography (ct) chest without contrast was performed which revealed new trace hemopericardium as well as circumferential hyper density involving the ascending thoracic aorta.It was unclear whether this represented as early dissection and/or intramural aortic hematoma (imh).Hemopericardium was secondary to isth major bleeding or clinically relevant non-major bleeding and intramural aortic hematoma was baseline condition.During cardiothoracic consultation, subject had mild chest pressure, small stable groin hematoma, denied dyspnea or palpitation, no vomiting nor nausea, cough edema or syncope was noted.On the same day, electrocardiogram (ekg) revealed ventricular rate of 53bpm, atrial fibrillation and sinus rhythm.However, no significant chest pains or ekg changes.At the time of event, the subject was on aspirin and clopidogrel was started.The event was considered to be resolved and subject was hemodynamically stable.Computed tomography angiography (cta) chest with contrast revealed intramural hematoma in the ascending aorta, enlargement of the ascending aorta measuring 4.4 x 4.4 cm and small pericardial effusion.However, no evidence of intimal dissection.The subject was clinically hemodynamically stable with no significant chest pain or ekg changes.Three days post procedure, the subject was discharged home in stable condition on aspirin (81 mg) and clopidogrel (75mg).At the time of reporting, the outcome of the event in lcx was ongoing.

• Brand Name: PROMUS ELITE
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15379142
• MDR Text Key: 299467240
• Report Number: 2124215-2022-33038
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• 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: 08/22/2022
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: White