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 11/20/2014

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2014-07891, mdr id 2134265-2014-07889.(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, index procedure was performed.The target lesion was 90% in-stent restenosis of a previously implanted unspecified stent located in the first obtuse marginal (om) artery and was 6.0 mm long with a reference vessel diameter of 3.00 mm.The lesion was treated with direct placement of a 3.00x8mm promus element¿ plus drug eluting stent, with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, a 2.25 mm x 16 mm promus drug eluting stent was implanted in the first om artery.In (b)(6) 2014, a 2.5 mm x 16 mm promus drug eluting stent was implanted in the mid left circumflex (lcx) artery.In (b)(6) 2014, the patient presented due to atherosclerotic cardiovascular disease with unstable angina.The patient was hospitalized and was referred for cardiac catheterization.Coronary angiography was performed and revealed 80% isr of the previously placed study stent and the 2.25 x 16 mm promus stent located in 1st om, and 70% isr of the previously placed 2.5 x 16 mm promus stent located in the mid lcx.The 80% isr in first om and the 70% isr in mid lcx were treated with balloon angioplasty with 10% residual stenosis.One day post procedure, the event was considered as resolved and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(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: 4343562
• MDR Text Key: 5174087
• Report Number: 2134265-2014-07888
• 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: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• 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: 0014987604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• 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