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

Model Number H7493911608300

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Atherosclerosis (1728); Reocclusion (1985)

Event Date 01/23/2014

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2014-07363.(b)(4).It was reported that atherosclerosis, angina and in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, coronary angiography and index procedure were performed.The target lesion was located in the first obtuse marginal (om1) branch with 90% isr of a previously placed unspecified stent and was 6.0 mm long with a reference vessel diameter of 3.00 mm.The lesion was treated with direct stent placement using a 3.00 x 8.00 mm promus element¿ plus stent with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented due to atherosclerotic cardiovascular disease with unstable angina and was hospitalized.The patient was referred for cardiac catheterization.Coronary angiography was performed and revealed 70% isr of the previously placed study stent located in om1 and was treated with balloon angioplasty with 10% residual stenosis.In addition, the 80% isr of a previously implanted unspecified stent in the right posterolateral (rpl) branch was treated with balloon angioplasty with 0% residual stenosis.One day post procedure, the event was considered as resolved and the patient was discharged.In (b)(6) 2014, the patient presented with ongoing typical chest pain and was subsequently diagnosed as unstable angina.Cardiac catheterization was recommended.The 95% isr located in the 1st om was treated with balloon angioplasty using a 3.0 x 15 mm emerge balloon.During angioplasty, water melon seeding was noted with the balloon.However, the post residual stenosis was 0% with timi flow 3.Hence, no action was taken.The event was considered as resolved and the patient was discharged on aspirin and clopidogrel in (b)(6) 2014, the patient presented with intermittent chest pain from several days radiating to his back and was subsequently diagnosed as atherosclerotic cardiovascular disease.Cardiac catheterization was recommended.The 90% isr located in the 1st om was treated with direct stent placement using 2.25 x 16 mm promus des with 0% residual stenosis.The event was considered as resolved and the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented with recurrent chest pain, dyspnea on exertion and shortness of breath and was diagnosed as atherosclerotic cardiovascular disease.Cardiac catheterization was recommended.The 70% stenosis located in the rpl was treated with balloon angioplasty using a 2.5 x 20 mm emerge balloon, with 10% residual stenosis.The event was considered as resolved and the subject was discharged on aspirin and clopidogrel.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint 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).

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

Same case as mdr id 2134265-2015-05790 and 2134265-2014-07363.It was further reported that in (b)(6) 2014, a 100% occlusion was noted in om1 however, no intervention was performed to treat this occlusion.

• 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: 4248488
• MDR Text Key: 15361806
• Report Number: 2134265-2014-06859
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2012
• Device Model Number: H7493911608300
• Device Catalogue Number: 39116-0830
• Device Lot Number: 14987604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR