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

Model Number H7493911312300

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Myocardial Infarction (1969); Thrombosis (2100); ST Segment Depression (2487)

Event Date 06/17/2012

Event Type  Injury  

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).

Event Description

Same case as mdr id# 2134265-2016-06608 and 2134265-2016-06619.(b)(4) clinical study.It was reported that myocardial infarction (mi) and stent thrombosis occurred.In (b)(6) 2011, the patient was referred for cardiac catheterization.Target lesion # 1 was a de novo lesion with chronic total occlusion located in the proximal right coronary artery (rca) extending to the mid rca with 100% stenosis and was 48mm long with a reference vessel diameter of 3.0mm.The lesion was treated with pre-dilatation and placement of a 3.00x12mm and a 2.75x38mm promus element ¿ stent.Following post dilation with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2011, a 2.75x24mm promus element ¿ stent was deployed in the mid rca for treatment of stent thrombosis in the rca.In (b)(6) 2012, the site reported an event of myocardial infarction.Cardiac enzymes were drawn and troponin values were elevated.On the same day an ecg was performed which revealed a non q-wave mi with st segment depression.Thrombosis was also discovered in the previously placed study stents located in the rca and the patient was prescribed prasugrel.Six days later the event was considered resolved without residual effects and the patient was discharged.In (b)(6) 2012, 100% total occlusion was noted in the previously placed study stents and the 2.75x24mm promus element ¿ stent located in the mid rca was treated with coronary artery bypass graft (cabg).Five days post procedure, the event was considered to be resolved without residual effects.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2012, the patient presented with atypical cardiac chest pain and was diagnosed with unstable angina.Seven days later, the patient was referred for elective surgery for triple vessel disease.

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5827151
• MDR Text Key: 50611968
• Report Number: 2134265-2016-06603
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2011
• Device Model Number: H7493911312300
• Device Catalogue Number: 39113-1230
• Device Lot Number: 0013613769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2010
• 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): Required Intervention
• Patient Age: 66 YR