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

Model Number H7493911428250

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Arrhythmia (1721); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); Reocclusion (1985); Vomiting (2144); ST Segment Depression (2487)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-12699 and 2134265-2016-12701.(b)(6) clinical study.It was reported that cardiac angina, myocardial infarction, and in-stent restenosis occurred.In (b)(6) 2012, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, the index procedure and coronary angiography were performed.Target lesion # 1 was a de novo lesion located in obtuse marginal (om1) with 75% stenosis and was 8 mm long with a reference vessel diameter of 2.5 mm.Target lesion # 1 was treated with direct stent placement using 2.50 mm x 12 mm and 2.5 x 8.00 mm promus element plus drug-eluting stents in overlapping manner.Following post dilatation, the residual stenosis was 0%.Target lesion # 2 was a de novo lesion located in proximal left anterior descending (lad) artery with 70% stenosis and was 20 mm long with a reference vessel diameter of 3.5 mm.Target lesion # 2 was treated with pre-dilatation and placement of a 3.50 mm x 24 mm promus element plus drug-eluting stent.Following post dilatation, the residual stenosis was 0%.Target lesion # 3 was a de novo lesion located in distal lad with 80% stenosis and was 24 mm long with a reference vessel diameter of 3.00 mm.Target lesion # 3 was treated with pre-dilatation and placement of a 2.50 mm x 28 mm promus element plus drug-eluting stent.Following post dilatation, the residual stenosis was 0%.Additionally, 80% stenosis in 3rd diagonal was treated with balloon angioplasty with 0% residual stenosis.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented with sudden onset of chest pain radiating to left arm, as well as nausea and vomiting.The patient was diagnosed with diabetic ketoacidosis and was found to be in cardiogenic shock.Patient was volume resuscitated for diabetic ketoacidosis but then went in acute respiratory failure and was intubated in emergency department.The patient was diagnosed with acute renal failure which was secondary to hypotension.The troponin i level was noted to be elevated and an event of myocardial infarction was reported.The patient was referred for cardiac catheterization and coronary angiography was performed.The 99% stenosis located in the proximal left circumflex (lcx) artery was treated with cutting balloon angioplasty and placement of a 3 mm x 12 mm synergy des monorail with 0% residual stenosis.Staged intervention of the lad was planned for the treatment of de novo as well as in-stent restenosis (isr) in the mid and distal vessel in near future.Five days later, the events were considered as resolved and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2017, the patient was hospitalized for planned intervention in the mid left anterior descending (lad) artery as well as the distal lad.The 90% in-stent restenosis in the distal lad was treated with balloon angioplasty using 2.5 x 20 mm nc emerge balloon, 2 x 20 mm non-bsc balloon and 2.5 x 20 mm emerge balloon and beta brachytherapy (covers all of the distal left anterior descending (lad) segment).Following post-dilatation using 2 x 20 mm non-bsc balloon and 2.5 x 20 mm emerge balloon, the residual stenosis was 0%.Additionally, 20% stenosis in the left main coronary artery (lmca) was treated with balloon angioplasty using 3 x 15 mm non-bsc balloon and a 3.5 x 12 mm nc emerge otw balloon with 0% residual stenosis.Also, 80% stenosis in the mid lad was treated with balloon angioplasty and placement of 3.00 mm x 26 mm non-bsc drug-eluting stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.

• 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: 6261651
• MDR Text Key: 65139627
• Report Number: 2134265-2016-12700
• 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: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2012
• Device Model Number: H7493911428250
• Device Catalogue Number: 39114-2825
• Device Lot Number: 14756043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR