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

Model Number H7493911320400

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that angina pectoris and in-stent restenosis occurred.In (b)(6) 2013, the patient presented with an unstable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed on the same day.The target lesion was located in proximal left anterior descending (lad) artery with 95% stenosis, and was 15mm long with a reference vessel diameter of 4mm.The target lesion was treated with pre-dilatation and placement of a 4.00x20mm promus element¿ drug-eluting stent.Following post dilatation, the residual stenosis was 0%.After three days, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient was diagnosed with an angina pectoris and was hospitalized on the same day.Subsequently, coronary angiography was performed.After three days, the 80% in-stent restenosis noted in the proximal lad which had previously placed study device extending up to mid lad stenosis was treated with percutaneous coronary intervention (pci) with 0% residual.Three days after, the outcome of 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: 7396171
• MDR Text Key: 104361358
• Report Number: 2134265-2018-03005
• 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: 03/22/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2014
• Device Model Number: H7493911320400
• Device Catalogue Number: 39113-2040
• Device Lot Number: 0015885543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• 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: 50 YR