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

Model Number H7493911416270

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Myocardial Infarction (1969); Reocclusion (1985)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.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.(b)(4).

Event Description

(b)(6) clinical study.It was reported that angina, myocardial infarction and in-stent restenosis occurred.In (b)(6) 2013, the patient presented due to myocardial infarction and was referred for cardiac catheterization.On the next day, coronary angiography and the index procedure were performed.The target lesion #1 was located in the proximal left anterior descending (lad) artery with 90% in-stent restenosis (isr) of bare metal stent (bms) and was 15mm long with a reference vessel diameter of 2.75mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.75x16mm promus element¿ plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.The target lesion #2 was a de novo lesion located in the proximal left circumflex (lcx) artery with 80% stenosis and was 10mm long with a reference vessel diameter of 2.75mm.Target lesion #2 was treated with pre-dilatation and placement of a 2.75mm x 20mm promus element¿ plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, patient presented to emergency department via emergency medical services (ems) with the complaints of recurrent chest pain associated with shortness of breath.The patient's cardiac enzymes were noted to be elevated and myocardial infarction was reported.Electrocardiogram revealed normal sinus rhythm, septal infract possible lateral infract.Subsequently, the patient was referred for cardiac catheterization and coronary angiography was performed.The 99% stenosis located in ostial portion of lcx was treated with balloon angioplasty and placement of 3.0 x 18mm non-bsc drug-eluting stent following post-dilation, the residual stenosis was 0% and timi 3 flow noted.On the next day, the event was considered as resolved.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 7290409
• MDR Text Key: 100729365
• Report Number: 2134265-2018-01277
• 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
• Report Date: 01/30/2018

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: 11/06/2013
• Device Model Number: H7493911416270
• Device Catalogue Number: 39114-1627
• Device Lot Number: 15744724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2013
• 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: 63 YR