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

Model Number H7493911416250

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Reocclusion (1985); Tachycardia (2095)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

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 myocardial infarction and restenosis occurred.In (b)(6) 2012, the subject presented with unstable angina (braunwald classification: iib) and was referred for cardiac catheterization.Target lesion #1 was a de novo lesion located in mid right coronary artery (rca) extended to distal rca with 75% stenosis and was 58 mm long with a reference vessel diameter of 3.0 mm.Target lesion #1 was treated with pre-dilatation and placement of 2.75 mm x 38 mm and 2.75 mm x 24 mm promus element plus stents in an overlapping fashion.Following post dilatation residual stenosis was 25%.Target lesion #2 was a de novo lesion located in the right posterior descending artery (r-pda) with 75% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.Target lesion #2 was treated with direct placement of a 2.50 mm x 16 mm promus element plus stent.Following post dilatation residual stenosis was 25%.The subject was discharged on aspirin and clopidogrel.In (b)(6) 2017, the subject presented with the complaints of chest pain associated with shortness of breath and was hospitalized on the same day.Chest x ray revealed interstitial thickening with no acute infiltrate.No vascular congestion or pneumothorax was seen.There was a mild cardiomegaly noted.The subject¿s troponin level was noted to be elevated.Electrocardiography (ekg) revealed sinus tachycardia with premature atrial complexes with aberrant conduction, left bundle branch block.The subject was referred for cardiac catheterization.The 90% stenosis located in r-pda was treated with plain balloon angioplasty following which 20% residual stenosis and timi 3 flow were noted.The event was considered as resolved.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the study stent was patent and the reported myocardial infarction was considered not related to the device.

• 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: 7211538
• MDR Text Key: 97944394
• Report Number: 2134265-2018-00264
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729807834
• UDI-Public: 08714729807834
• 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: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2013
• Device Model Number: H7493911416250
• Device Catalogue Number: 39114-1625
• Device Lot Number: 0015584585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR