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

Model Number H7493911320300

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

Patient Problems Atherosclerosis (1728); Chest Pain (1776); Reocclusion (1985)

Event Date 11/27/2013

Event Type  Injury  

Event Description

Same case as mdr id: 2134265-2013-09395 and 2134265-2013-09407.(b)(4) clinical study.It was reported that cardiac chest pain and restenosis occurred.On (b)(6) 2013, identified the subject's qualifying condition was stable angina and the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal lad (left anterior descending) extending into the mid lad with 99 % stenosis, a length of 17.0 mm, and a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilatation, placement of 3.00 x 20 mm and 3.00 x 20 mm study stents, with 0% residual stenosis.The target lesion 2 was located in the 1st diagonal with 99% stenosis, a length of 23 mm, and a reference vessel diameter of 2.50 mm.The target lesion 2 was treated with pre-dilatation, placement of a 2.50 x 24 mm study stent, with 0% residual stenosis.The subject was discharged on the same day on aspirin and clopidogrel.On (b)(6) 2013, the subject was hospitalized and was treated with medication.1 day after, the site reported an event of cardiac chest pain and the subject underwent angiography.6 days after, the subject underwent cabg to the proximal lad and also to 1st diagonal.The subject was recovering and the event was resolving at the time of this report.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).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).

Manufacturer Narrative

Event date corrected from (b)(6) 2013.(b)(4).

Event Description

Same case as mdr id: 2134265-2013-09395 and 2134265-2013-09407.(b)(4).It was reported that cardiac chest pain and restenosis occurred.On (b)(6) 2013, identified the subject's qualifying condition was stable angina and the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal lad (left anterior descending) extending into the mid lad with 99 % stenosis, a length of 17.0 mm, and a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilatation, placement of 3.00 x 20 mm and 3.00 x 20 mm study stents, with 0% residual stenosis.The target lesion 2 was located in the 1st diagonal with 99% stenosis, a length of 23 mm, and a reference vessel diameter of 2.50 mm.The target lesion 2 was treated with pre-dilatation, placement of a 2.50 x 24 mm study stent, with 0% residual stenosis.The subject was discharged on the same day on aspirin and clopidogrel.On (b)(6) 2013, the subject was hospitalized and was treated with medication.One day after, the site reported an event of cardiac chest pain and the subject underwent angiography.Six days after, the subject underwent cabg to the proximal lad and also to 1st diagonal.The subject was recovering and the event was resolving at the time of this report.

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2014-06335, 2134265-2013-09395 and 2134265-2013-09407.It was further reported that an event of "coronary atherosclerotic heart disease" instead of previously reported event of cardiac chest pain.A 3.5x24mm promus element stent was also implanted in the proximal lad lesion in (b)(6) 2013.14 days following cabg procedure the patient was discharged.

• Brand Name: PROMUS ELEMENT ?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3557257
• MDR Text Key: 4212195
• Report Number: 2134265-2013-09394
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: H7493911320300
• Device Catalogue Number: 39113-2030
• Device Lot Number: 15615538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR