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

Model Number H7493911320300

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 09/07/2017

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

(b)(6) clinical study.It was reported that in-stent restenosis occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 20 mm promus element¿ drug-eluting stent was advanced to treat the lesion.The event was considered to be resolved.In (b)(6) 2016, the patient presented with unstable angina and was hospitalized on the same day.The patient was on aspirin, clopidogrel and atorvastatin.A week after, the patient was discharged.In (b)(6) 2017, coronary angiography was performed and revealed 40-85% stenosis in the lad.The target lesion was treated with a non bsc stent.

• 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: 7286740
• MDR Text Key: 100601878
• Report Number: 2134265-2018-01297
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 01/26/2018

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 Model Number: H7493911320300
• Device Catalogue Number: 39113-2030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 79 YR