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

Model Number H7493911412250

Device Problem Occlusion Within Device (1423)

Patient Problems Headache (1880); Nausea (1970); Reocclusion (1985)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device was not received 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

(b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2012, the patient's qualifying condition was unstable angina and the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was a de novo lesion located in the mid left anterior descending (lad) with 85% stenosis and was 10mm long with a reference vessel diameter of 2.5mm.The target lesion was treated with direct placement of a 2.50x12mm promus element¿ plus study stent.Following post dilatation the residual stenosis was 0%.Two days post procedure, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2016, the patient apparently fell out of the bed.However, the patient did not notice any seizure activity.The emergency medical services found that the patient was a little postictal with mild headache and mild nausea.The patient denied of vomiting and chest pain.The patient¿s left side head was sore due to fall.The patient was admitted with the diagnosis of syncope versus seizure.The patient was treated with medication in response to the events.Four days from the onset of symptoms, the patient was referred for cardiac catheterization due to patient¿s risk factor which include prior percutaneous coronary intervention.Coronary angiography revealed 60% in-stent restenosis of study stent, 65-70% stenosis just distal to the study stent.The following day, the 75% stenosis located in distal lad was treated with placement of 2.25 x 30mm non-bsc drug-eluting stent with 0% residual stenosis.Two days after, the event was considered as resolved and the patient was discharged with a home vent monitor and follow-up cardiology.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7053567
• MDR Text Key: 92785999
• Report Number: 2134265-2017-11510
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2013
• Device Model Number: H7493911412250
• Device Catalogue Number: 39114-1225
• Device Lot Number: 15400873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2012
• 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: 71 YR