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

Model Number H7493911416350

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Dyspnea (1816); Fatigue (1849); Reocclusion (1985); Pain (1994); Weakness (2145)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.The device was not returned for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per product specification.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

It was reported that the patient experienced cardiac angina and in-stent restenosis occurred.In (b)(6) 2013, the patient presented due to unstable angina.Subsequently, the index procedure and coronary angiography were performed.The target lesion was a de novo lesion located in the mid right coronary artery (rca) with 99% stenosis and was 12mm long with a reference vessel diameter of 3.75mm.The target lesion was treated with pre-dilatation and placement of a 3.50x16mm promus element¿ plus drug-eluting stent.Following post dilatation residual stenosis was 0%.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient came for a follow-up visit for chronic coronary disease and severe dyslipoproteinemia.The patient had a generalized fatigue, weakness, shortness of breath and pain in her upper arms.The patient was treated with medication in response to the event.The patient was referred for cardiac catheterization due to chest pain, dyspnea and positive stress test.The 99% stenosis from mid rca to distal rca was treated with placement of 3.00 x 32mm synergy stent with 0% residual stenosis.On the same day, the event was considered as resolved.In (b)(6) 2017, the patient was diagnosed with cardiac angina.Subsequently, the patient was treated with stent to left circumflex (lcx) artery.On the same day, outcome of the event was considered as resolved.

• 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: 6957035
• MDR Text Key: 89564491
• Report Number: 2134265-2017-10283
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2013
• Device Model Number: H7493911416350
• Device Catalogue Number: 39114-1635
• Device Lot Number: 15474826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2012
• 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: 79 YR