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

Model Number H7493911328300

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Promus element (b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2014, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the proximal left anterior descending (lad) artery with 70% stenosis and was 24mm long with a reference vessel diameter of 3.0mm.The target lesion was treated with direct placement of a 3.00x28mm promus element ¿ drug-eluting stent.Following post-dilatation, residual stenosis was 0%.After four days, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, the patient was noted with in-stent restenosis and hospitalized on the same day.After eight days, the 80% stenosis noted in the left main coronary artery (lmca) extending up to proximal lad which had previously placed study stent was treated with stent implantation.Post intervention, the residual stenosis was 0%.Three days after, 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: 7637637
• MDR Text Key: 112314037
• Report Number: 2134265-2018-05826
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: H7493911328300
• Device Catalogue Number: 39113-2830
• Device Lot Number: 16384059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2013
• 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: 74 YR