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

Model Number H7493911412250

Device Problem Occlusion Within Device (1423)

Patient Problems Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); Reocclusion (1985); ST Segment Elevation (2059); Obstruction/Occlusion (2422); Sweating (2444)

Event Date 12/04/2014

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2014-08159.(b)(4).It was reported that st elevation myocardial infarction (stemi), in-stent restenosis (isr) and small filling defect occurred.In (b)(6) 2011, the patient presented due to angina and was referred for cardiac catheterization.The right coronary artery (rca) was treated with placement of 5 overlapping stents.A 3.5 x 15 mm promus stent deployed in ostium of rca, 3.0 x 32 mm and 3.0 x 38 mm promus stents deployed in mid rca, 3.0 x 38 mm promus stent deployed in distal rca and 2.25 x 28 mm ion stent deployed in proximal right posterior descending artery (r-pda).Following post-dilatation residual stenosis was 0%.In (b)(6) 2012, the patient presented due to unstable angina and mi.Cardiac catheterization was recommended.Subsequently, coronary angiography and the index procedure were performed.The target lesion #1 was a de novo lesion located in first obtuse marginal (om1) with 90% stenosis and was 8 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with direct stent placement using a 2.5 x 12 mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0%.Target lesion # 2 was a de novo lesion long lesion located in mid left anterior descending (lad) artery extending to distal lad with 70% stenosis and was 34 mm long with a reference vessel diameter of 2.75 mm.It was treated with direct stent placement using a 2.75 x 38 mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0%.Two days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented due to severe chest discomfort with nausea, dyspnea and diaphoresis.The patient was diagnosed with stemi and was hospitalized.Cardiac enzymes were elevated and electrocardiogram (ecg) showed inferior mi.Coronary angiography was performed and revealed patent stents in proximal and mid lad, 90% isr of the previously placed study stent located in om1 and stent thrombosis of the previously placed 3.0 x 32 mm and 3.0 x 38 mm promus stents in mid rca, 3.0 x 38 mm promus stent in distal rca and 2.25 x 28 mm ion stent in proximal r-pda.The 90% isr in omi was treated with balloon angioplasty and placement of a 2.75 x 38 mm promus drug eluting stent.Follow up angiography revealed additional small filling defect at the end of the stented segment and was treated with additional angioplasty resulting in 0% residual stenosis.Angioplasty was also performed of the mid rca and r-pda with 0% residual stenosis.Two days 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: 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).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the stents indicated as promus in the initial mdr report were actually promus element plus stents.Same case as mdr id: 2134265-2014-08159, 2134265-2015-02903, 2134265-2015-02904, 2134265-2015-02905, 2134265-2015-02906.

• Brand Name: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4393205
• MDR Text Key: 5303829
• Report Number: 2134265-2014-08157
• 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,Followup
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2013
• Device Model Number: H7493911412250
• Device Catalogue Number: 39114-1225
• Device Lot Number: 15526346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• 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: 42 YR