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

Model Number H7493911316300

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Ischemic Heart Disease (2493)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: as the stent was implanted the device will not be returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as: 2134265-2017-10513 and 2134265-2017-10516.(b)(6) clinical study.It was reported that stent restenosis occurred and the patient experienced coronary heart disease.On (b)(6) 2014, the patient presented with an unstable angina (braunwald classification: iia) and was referred for cardiac catheterization.Subsequently, the index procedure was performed.Target lesion #1 was located in the mid left coronary artery (lad) and was treated by placement of a 2.50x16mm promus element ¿ stent.Target lesion #2 was located in the distal left circumflex artery and was treated by placement of a 3.00x16mm promus element ¿ stent.Target lesion #3 was located in the proximal lad and was treated by placement of a 3.50x20mm promus element ¿ stent.On (b)(6) 2014, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2015, 591 days post index procedure, the patient was diagnosed with coronary atherosclerotic heart disease after unstable angina pectoris restenosis and was hospitalized on the same day.On (b)(6) 2015, coronary angiography was performed which revealed the 1st diagonal (target vessel) was 80% stenosed.It was treated with percutaneous coronary intervention (pci) with 0% residual stenosis.The patient then had a blood transfusion.On (b)(6) 2015, the event was considered to be recovered/resolved and the patient was discharged on the same day.

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6976093
• MDR Text Key: 90203262
• Report Number: 2134265-2017-10515
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2014
• Device Model Number: H7493911316300
• Device Catalogue Number: 39113-1630
• Device Lot Number: 0016087232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR