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

Model Number H7493911412300

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Dyspnea (1816); Reocclusion (1985); Chest Tightness/Pressure (2463)

Event Date 04/24/2014

Event Type  Injury  

Event Description

Same case as mdr id# 2134265-2015-05119 and 2134265-2015-05107.(b)(4) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2013, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.Target lesion # 1 was a de novo lesion located in the 1st diagonal artery with 70% stenosis and was 12 mm long with a reference vessel diameter of 2.25 mm.The target lesion # 1 was treated with pre-dilatation and placement of a 2.25x12mm promus element¿ plus stent with 0% residual stenosis.Target lesion # 2 was an ostial lesion located in the right posterior descending artery (r-pda) with 95% stenosis and was 16 mm long with a reference vessel diameter of 3.5 mm.The target lesion # 2 was treated with pre-dilatation and placement of a 3.00x16mm promus element¿ plus stent.Following post dilation, residual stenosis was 0%.Post deployment of 3.00x16mm promus element¿ plus stent in rpda, there was a pinching of the right posterolateral (rpl) artery noted.This was treated by placement of 3.00x12mm promus element¿ plus stent overlapping proximally with the previously placed stent (culotte fashion).Post which there was excellent angiographic result.Target lesion # 3 was a de novo lesion located in 1st rpl with 20% stenosis and was 12 mm long with a reference vessel diameter of 3.0 mm.Target lesion # 3 was treated with pre-dilatation and placement of a 3.00x12mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0%.The following day, the patient was discharged on aspirin and prasugrel.In (b)(6) 2014, the patient presented due to chest tightness and excertional dyspnea and was diagnosed with unstable angina.Subsequently, the patient was hospitalized and cardiac catheterization was referred.Coronary angiography revealed a high grade in-stent restenosis (isr) of previously placed study stents at rpda and rpl.The isr of the study stents deployed at rpda and rpl was treated using cutting balloon angioplasty following which there was a brisk timi 3 flow in the vessel.After one day, the event was considered resolved and the patient was discharged on aspirin and prasugrel.

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 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).

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4974517
• MDR Text Key: 6076481
• Report Number: 2134265-2015-05108
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2013
• Device Model Number: H7493911412300
• Device Catalogue Number: 39114-1230
• Device Lot Number: 15330179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2012
• 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: 40 YR