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

Model Number H7493911432220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiomyopathy (1764); Occlusion (1984)

Event Date 09/14/2017

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

Same case as mdr id#: 2134265-2017-10003 and 2134265-2017-10005.(b)(4) clinical study.It was reported that restenosis occurred.In (b)(6) 2013, index procedure was performed.Target lesion #1 was a de novo lesion located in the distal left circumflex artery with 95% stenosis and was 20 mm long with a reference vessel diameter of 2.60 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 24 mm promus element plus stent.Following post dilatation, residual stenosis was 0%.Target lesion #2 was a de novo and ostial lesion located in the proximal left anterior descending artery (lad) with 50% stenosis and was 30 mm long with a reference vessel diameter of 2.60 mm.The lesion was treated with direct placement of a 2.50 x 32 mm promus element plus stent.Following post dilatation, residual stenosis was 0%.Target lesion #3 was a de novo lesion located in the mid lad with 95% stenosis and was 28 mm long with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.25 x 32 mm and 2.50 x 38 mm promus element plus stents in an overlapping manner.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 was hospitalized.Upon admission in emergency room, echo revealed newly decreased ejection fraction (ef) of 15-20%.The patient was diagnosed with ischemic cardiomyopathy.Due to the decrease in the ef the patient was referred for further cardiac evaluation and underwent myocardial perfusion imaging (mpi) which revealed large anteroseptal defect which was only mildly reversible suggestive of anteroseptal infarct or ischemia.Inferior wall had a paradoxical defect which likely due to soft tissue attenuation.Small size, mild intensity inferolateral partially reversible defect was also seen and could be due to ischemia or soft tissue attenuation.Since the mpi results were abnormal, the patient was referred for cardiac catheterization.Four days later, 70% isr was noted in the proximal lad, mild isr in the stent extending into the distal vessel, 70% stenosis in the distal lad.On the same day, the 70% isr in the proximal lad was treated with direct placement of a 3.00x28mm synergy stent.Following post-dilatation, residual stenosis was 0%.On the following day, the event was considered as resolved and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the site has confirmed that the study stents placed in the mid lad were patent.The site also confirmed that the study stent placed in the distal lcx was patent.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 6926227
• MDR Text Key: 88931103
• Report Number: 2134265-2017-10004
• 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,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: H7493911432220
• Device Catalogue Number: 39114-3222
• Device Lot Number: 15698394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• 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): Other
• Patient Age: 61 YR