MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926020300

Device Problem Occlusion Within Device (1423)

Patient Problems Bradycardia (1751); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Ventricular Tachycardia (2132)

Event Date 08/06/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr.: device not returned therefore analysis of complaint device could not be performed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id 2134265-2017-08816 and 2134265-2017-08817.It was reported that stent thrombosis occurred.In (b)(6) 2017, the patient presented through the emergency room with complaints of shortness of breath and chest pain.The patient was found to have no acute st-t changes, but had significant metabolic abnormalities.The patient had borderline troponin elevation.The patient was sent to the intensive care unit (icu) with a white count of 23,000 and lactic acidosis.Broad-spectrum antibiotics was then started.Early in the morning, the patient's pain started to get worse and despite being on intravenous (iv) heparin drip and topical nitrates, the patient was having more chest pain and was advised cardiac catheterization.His troponin was elevated.The patient was taken to the cardiac cath lab.Left wrist was prepped and draped in the usual sterile fashion.After local anesthesia, left radial artery was punctured without difficulty and a 6-french non-bsc sheath was placed.Coronary angiogram was then performed.The right amplatz guide catheter was engaged without difficulty and a long non-bsc guidewire was passed across the lesion.A non-bsc guide extension catheter was also placed for better support.Initial pre-dilatation of the lesion were done with a 1.25mm balloon catheter, followed by placement of the non-bsc guide extension catheter deep in the right coronary artery (rca) and balloon angioplasty with a 2.0x15mm balloon catheter was done.This was followed by placement of a 2.5x15 non-compliant balloon in the entire rca.There was heavy amount of calcification and two non-bsc balloons had ruptured.A 2.5x15 quantum apex balloon catheter was then advanced and was initially inflated at 10 atmospheres for 25 seconds, then inflated for the second time at 12 atmospheres for 16 seconds.Once the non-bsc guide extension catheter was placed deep, the lesion in the mid rca was stented with a 3.0x20mm synergy drug-eluting stent at 14 atmospheres.Attempt to pass the stent into the distal aspect was not successful.However, after multiple trying, the patient had timi 3 flow, was completely chest pain free ad no st-t changes and hence the procedure was completed.The patient was doing well from ischemic standpoint.The patient was completely chest pain free.A possible rotational atherectomy going from the groin approach was planned to address the issue of the distal rca.Fifteen days later, the patient was taken to the cardiac cath lab for staged intervention.Right groin was prepped and draped in the usual sterile fashion and after local anesthesia, right common femoral artery was punctured without difficulty and a 7-french sheath was placed.The patient was given a total of 8000 units of heparin.Coronary angiogram was then performed.This was followed by passing a non-bsc guidewire across the lesion in the left anterior descending artery (lad) and direct stenting with a 2.5x16mm synergy drug-eluting stent was done.This was followed by placement of 2.75x15mm non-complaint balloon catheter at 16 atmospheres for a period of 30 seconds.This opened up the vessel extremely well and excellent flow was noted.Left circumflex artery (lcx) had a high-grade 90 stenosis in the distal aspect which was also treated by passing a non-bsc guidewire across the lesion and ballooning with a 2.0x15m balloon catheter was done, followed by stenting with a 2.25x24mm synergy drug-eluting stent.This was deployed up to 12 atmospheres for period of 30 seconds.Excellent flow was noted.The diagnostic angiogram of the rca was done, which showed presence of patency of the mid-rca with presence of a residual 50% stenosis of the mid to distal rca, which had extremely good flow, hence no intervention was done.The right groin was sealed with a 6-french non-bsc vascular closure device.In (b)(6) 2017, the patient came in to emergency room with severe chest pain.The patient had ventricular tachycardia-fibrillation, required defibrillation cardioversion, and placed on iv cordarone.The patient was brought in the cath lab.Initially the procedure was performed via the right femoral approach.A 6fr non-bsc sheath was used.Coronary angiogram was then performed.The patient had in-stent thrombosis.There was a moderate disease proximal to stented area of more than 50% to 70% stenosis.The stent at the distal cx posterolateral branch is clotted with no flow.The rca also showed in-stent thrombosis in the proximal segment.A non-bsc heart pump catheter was placed, with good position and good cardiac output throughout the procedure, and it helped tremendously, with the patient being hypotensive and in junctional bradycardia.Angioplasty and stenting of the mid lad distal and proximal to the stented area was carried out with much improved angiographic results.There was no reflow intermittently noted distally.The artery, to begin with, was relatively narrow distally.Angioplasty of the in-stent thrombosis of the distal cx artery also was carried out and flow was reestablished into the posterolateral branch.Angioplasty and stenting with the non-bsc guide extension catheter of the mid rca again was carried out, opened up the rca, yet the distal portion of the rca remained occluded probably due to no reflow.Staining of the inferior wall was noted during the rca stenting, the wire was one of the side branches and was re-negotiated into the main artery distally.It did not appear that the patient had a free fluid, but an echocardiogram will be performed for verification.The patient's overall hemodynamics were stable.The patient was kept on a heart pump overnight and also continued the iv aggrastat.Aspirin was continued and the patient should probably be switched to either effient or brilinta.The patient will be transferred to the icu for close up monitoring.Two days later, the patient became non responsive.Respirations were provided by ventilator.Six days later, the patient had been transferred to another facility.The patient was alive but had required a partial bowel resection due to sepsis (dead bowel).

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 6844179
• MDR Text Key: 84930991
• Report Number: 2134265-2017-08815
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: (01)08714729840176(17)20180302(10)20365226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2017

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
• Device Expiration Date: 03/02/2018
• Device Model Number: H7493926020300
• Device Catalogue Number: 39260-2030
• Device Lot Number: 20365226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• 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: 40 YR
• Patient Weight: 75