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); Chest Pain (1776); Dyspnea (1816); Reocclusion (1985)

Event Date 05/04/2015

Event Type  Injury  

Event Description

Same case as mdr id: 2134265-2015-02008 and 2134265-2015-02009.(b)(4) clinical study.It was reported that angina, atherosclerosis and in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient presented due to unstable angina.Following day, the coronary angiography and index procedure were performed respectively.The target lesion was located in first obtuse marginal (om1) with 90% in-stent restenosis 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, resulting with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the 2.25 x 16 mm promus premier¿ stent was implanted in the om1.In (b)(6) 2014, the 2.5 x 16 mm promus element plus stent was implanted in the middle of left circumflex (lcx).In (b)(6) 2015, the patient presented with one week history of recurrent chest and mid-back discomfort.The coronary angiography revealed 80% mid stenosis isr of 2.5 x 16 mm promus element plus stent, 80% stenosis om1 isr of study stent as well as the 2.25 x 16 mm promus premier¿ stent.Subsequently, the om1 was treated with balloon angioplasty, resulting with 0% residual stenosis.Additionally, the stenosis in distal lcx was treated with balloon angioplasty with 20% residual stenosis.Also, stenosis in the right posterolateral (rpl) branch was treated with balloon angioplasty with 0% residual stenosis.One day post procedure, the event was considered resolved and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

Device is a combination product.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

(b)(4).

Event Description

It was further reported that in (b)(6) 2015, the patient presented emergently due to chest pain and shortness of breath (sob).Subsequently, coronary angiography revealed 90% in-stent restenosis (isr) of 2.5 x 16 mm promus premier⠓tent (commercial product) in distal portion; 80% isr of study stent and of 2.25 mm promus premier stent (commercial product) in om1.The 90% isr in distal left circumflex (lcx) was treated with direct stent placement using a 2.5mm x 20mm promus drug-eluting stent, resulting to 0% residual stenosis.

• 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: 4667955
• MDR Text Key: 5729038
• Report Number: 2134265-2015-02007
• 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: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 04/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2015
• 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): Required Intervention
• Patient Age: 63 YR