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

Model Number H7493911438300

Device Problems Occlusion Within Device (1423); Insufficient Information (3190)

Patient Problems Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Thrombosis (2100); Stenosis (2263)

Event Date 04/23/2014

Event Type  Death  

Manufacturer Narrative

Device is a combination product.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 2134265-2016-00404.It was reported that the patient died.In (b)(6) 2012, the patient presented with unstable angina and myocardial infarction and was referred for cardiac catheterization.On the same day, index procedure was performed.Target lesion # 1 was a de novo lesion extending from left main coronary artery to the proximal left anterior descending artery with 90% stenosis and was 16mm long with a reference vessel diameter of 3.5mm.Target lesion# 1 was treated with direct stent placement of a 3.50x20mm promus element plus stent with 0% residual stenosis.Target lesion # 2 was a de novo lesion extending from the distal portion of the saphenous vein graft to the first obtuse marginal artery with 99% stenosis and was 32mm long with a reference vessel diameter of 3.00mm.Target lesion# 2 was treated with direct stent placement of a 3.00x38mm promus element plus stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient died due to an unknown cause.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2014, the patient was admitted to the emergency room with complaints of progressive worsening dyspnea with minimal exertion and congestive heart failure (chf).The patient was known to have history of aortic valve stenosis for which the patient elected no further intervention and has been maintained on medical management.Subsequently, the patient was evaluated for surgical and minimally invasive surgical options.However, the patient declined any mechanical intervention and opted for comfort care.Four days later, the patient requested to return home with hospice care.Seven days post discharge, the patient expired.The cause of death was severe aortic stenosis.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that stent thrombosis occurred per adjudication.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5426878
• MDR Text Key: 37887646
• Report Number: 2134265-2016-00397
• 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,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2013
• Device Model Number: H7493911438300
• Device Catalogue Number: 39114-3830
• Device Lot Number: 0015119772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2012
• 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): Death
• Patient Age: 83 YR