MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE PROMUS ELEMENT¿ PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911428350

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Dyspnea (1816); Reocclusion (1985); ST Segment Elevation (2059)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.The device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12085; 2134265-2017-12084; 2134265-2017-12074.(b)(4) clinical study.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient presented due to stable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.Target lesion #1 was a de novo lesion with chronic total occlusion located in the distal right coronary artery (rca) and was 20mmg long with a reference vessel diameter of 2.7mm.The lesion was treated with pre-dilatation and placement of a 2.50x28mm promus element plus stent with proximal overlap to des.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was a de novo lesion with chronic total occlusion located in the mid rca and was 10 mm long with a reference vessel diameter of 3.50 mm.The lesion was treated with pre-dilatation and placement of a 3.00x28 mm promus element plus stent with proximal and distal overlap to des.Following post -dilatation residual stenosis was 0%.Target lesion #3 was a long de novo lesion with chronic total occlusion located from proximal rca to mid rca and was 30 mm long with a reference vessel diameter of 4.00 mm.The lesion was treated with pre-dilatation and placement of a 3.00x28mm with proximal and distal overlap to des and 3.50 x 28 mm promus element plus stents with distal overlap to des.Following post-dilatation, residual stenosis was 0%.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient had a follow-up due to an abnormal lexiscan nuclear stress test which was performed on (b)(6) 2017.The patient stated that he had frequent chest pain that lasted for few minutes with shortness of breath.The patient took sublingual nitroglycerin 2-3 times.The patient was referred for cardiac catheterization due to known coronary artery disease with concerning angina symptoms.In (b)(6) 2017, the 90% in-stent restenosis of the distal rca was treated with pre-dilatation and placement of 2.5x14mm non-bsc drug-eluting stent with no residual stenosis and with timi flow iii.On the same day, the 90% in-stent restenosis of mid rca was treated with pre-dilatation and placement of 3.0x26mm non-bsc drug-eluting stent with no residual stenosis and with timi flow ii.On the next day, the patent was discharged.Nine days later, the patient presented to emergency room with throat, ear and jaw discomfort and some chest tightness.The patient burped a lot and took an antacid but it did not help.The patient's electrocardiogram (ekg) revealed slight st elevations the inferior leads with some beat-to-beat variation.The patient was treated with heparin bolus drip.The follow-up ekg revealed normalization of the st elevations with some t -wave inversions essentially similar to baseline ekg.The patient still had some degree of chest discomfort although significantly less than earlier.In view of symptoms and recent intervention less than 2 weeks ago, the patient was referred for cardiac catheterization and further evaluation and treatment.Coronary angiography revealed 50% in-stent restenosis of distal rca stent with the haziness suggestive of a possible small thrombus within the distal stent and its mid portion were treated with percutaneous transluminal angioplasty within the area of the previously implanted distal non-bsc stent.Four days later, the patient complained of increased shortness of breath overnight and increased lower extremity edema from baseline.The patient was given a dose of intravenous furosemide, which improved her dyspnea greatly and was prescribed furosemide 40 mg by mouth daily for lower extremity edema.The patient's condition improved clinically.On the following day, the patient was discharged from the hospital.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2017, the patient was treated medically and their anginal symptoms were progressively increasing.In (b)(6) 2017, the patient was also given 1 bolus of integrilin in the emergency room.The patient's ekg also revealed prolonged pr interval.Four days later the patient was anemic with hemoglobin of 9.2 and hematocrit of 29.5.The patient's anemia from this admission was inferred due to right groin hematoma post procedure which was clinically improving.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 7114288
• MDR Text Key: 94788471
• Report Number: 2134265-2017-12086
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• 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,Followup
• Report Date: 11/17/2017

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: 11/14/2012
• Device Model Number: H7493911428350
• Device Catalogue Number: 39114-2835
• Device Lot Number: 14915917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2012
• 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: 53 YR