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

Model Number H7493911412300

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

Patient Problems Abdominal Pain (1685); Death (1802); Dyspnea (1816); Edema (1820)

Event Date 12/22/2015

Event Type  Death  

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: 2134265-2016-00837.(b)(4).It was reported that the patient died.In (b)(6) 2013, the patient presented due to unstable angina and was referred for cardiac catheterization.Target lesion #1 was a de novo lesion located in the mid right coronary artery (rca) with 75% stenosis and was 8mm long with a reference vessel diameter of 3.00mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00x12mm promus element¿ plus drug-eluting stent.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was a de novo lesion located in the proximal rca with 90% stenosis and was 8mm long with a reference vessel diameter of 3.00mm.Target lesion #2 was treated with pre-dilatation and placement of a 3.00x12mm promus element¿ plus drug-eluting stent.Following post-dilatation, residual stenosis was 0%.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient presented for follow up with complaint of severe shortness of breath, severe edema to upper and lower bilateral extremities, distended abdomen, abdominal pain and 3 pillow orthopnea.Subsequently, the patient was hospitalized on the same day.The patient was currently unable to walk due to severity of edema and was also noted to have developed decubitus ulcers.The patient was placed on medications for multiple problems.Six days later, inspite of intubation, the patient was without spontaneous respiration and was unresponsive to verbal or painful stimuli and was pronounced dead.The cause of death was acute on chronic systolic heart failure.

• 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: 5458208
• MDR Text Key: 38960068
• Report Number: 2134265-2016-00838
• 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: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2013
• Device Model Number: H7493911412300
• Device Catalogue Number: 39114-1230
• Device Lot Number: 15602431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2012
• 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: 66 YR