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

Model Number H7493911420270

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

Patient Problems Atherosclerosis (1728); Cardiomyopathy (1764); Congestive Heart Failure (1783); Death (1802)

Event Date 02/18/2016

Event Type  Death  

Manufacturer Narrative

(b)(4) 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

(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2012, the patient presented die to stable angina and silent ischemia and was referred for cardiac catheterization.Subsequently, the index procedure was performed.Target lesion #1 was located in the proximal left circumflex (lcx) with 80% in stent restenosis and was 18 mm long with a reference vessel diameter of 2.75 mm.The lesion was treated with direct stent placement using a 2.75x20mm promus element plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.Target lesion #2 was a de novo lesion located in the 1st diagonal branch with 80% stenosis and was 10 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and attempted placement of 2.50mmx12mm promus element plus drug-eluting stent; however, the device could not cross the lesion.Residual stenosis was 45%.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient was diagnosed with chronic systolic congestive heart failure (chf), ischemic cardiomyopathy and atherosclerotic heart disease of native coronary arteries.The patient was on a continuous dobutamine drip for treatment of congestive heart failure.On the following day, the patient was admitted in order to manage his chf further which the patient had a decline in functional status.Subsequently, dnr status was initiated and the patient was transferred to hospice care.In (b)(6) 2016, the patient expired in hospice care due to chronic systolic heart failure.No death certificate is available and it is unknown if the autopsy was performed or not.

• 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: 5741126
• MDR Text Key: 47904759
• Report Number: 2134265-2016-05155
• 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: 05/23/2016

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: 07/10/2013
• Device Model Number: H7493911420270
• Device Catalogue Number: 39114-2027
• Device Lot Number: 0015457707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2012
• 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: 81 YR