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

Model Number H7493911328220

Device Problem Occlusion Within Device (1423)

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

Event Date 02/27/2014

Event Type  Injury  

Event Description

(b)(4).It was reported that the patient experienced chest distress and in-stent restenosis was identified.In (b)(6) 2013, the patient presented due to unstable angina and was referred for cardiac catheterization.The target lesion #1 was located in the proximal left circumflex (lcx) extending into the distal lcx with 100% stenosis, and was 41 mm long, with a reference vessel diameter of 3.0 mm.The target lesion #1 was treated with pre-dilatation and placement of 2.25 x 28 mm and 3.00 x 16 mm promus element ¿ study stents.Following post-dilatation residual stenosis was 10%.Three days later, the patient was discharged on aspirin and clopidogrel.In (b)(6)2014, the patient presented with a chief complaint of chest distress which had been persistent for half a year post index procedure, and underwent hospitalization on the same day.One day later, diagnostic angiography revealed 85% in-stent restenosis in the distal lcx which was subsequently treated with percutaneous transluminal coronary angioplasty (ptca).Following intervention the residual stenosis was 0%.Two days later, the event was considered as recovered/ resolved and the patient was discharged on the same day.

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).

• 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: 4414452
• MDR Text Key: 18890731
• Report Number: 2134265-2015-00005
• 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
• Report Date: 12/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2014
• Device Model Number: H7493911328220
• Device Catalogue Number: 39113-2822
• Device Lot Number: 15994322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR