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

Model Number H7493911332270

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Congestive Heart Failure (1783); Reocclusion (1985)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is 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).

Event Description

(b)(4).Same case as mdr id: 2134265-2016-01522 and 2134265-2016-01523.It was reported that worsening heart insufficiency occurred.The patient was enrolled in the (b)(4) study in (b)(6) 2011.They presented due to unstable angina and was referred for cardiac catheterization.The first target lesion was a de novo lesion located in the proximal right coronary artery (rca) with 80 % stenosis and was 12 mm long with a reference vessel diameter of 3.00 mm.This lesion was treated with direct placement of a 3.00 mm x 16 mm promus element stent.Following post dilatation, residual stenosis was 0%.The second target lesion was a de novo lesion located in the distal rca with 99 % stenosis and was 20 mm long with a reference vessel diameter of 2.5 mm.This lesion was treated with pre-dilatation and placement of a 2.75 mm x 32 mm and 2.50 mm x 32 mm promus element stents.Following post dilatation, residual stenosis was 5%.One day later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient was diagnosed with worsening heart insufficiency and atrial fibrillation and was hospitalized on the same day.Revascularization was done to treat the worsening heart insufficiency which failed.While electrocardioversion was done to treat atrial fibrillation.Five days later, the events were considered to be resolved without residual effects and the subject was discharged on the same day.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2015, coronary angiography revealed complete occlusion of mid rca.The study stent was placed in distal rca while the stent thrombosis was identified in mid rca.One day later, percutaneous coronary intervention (pci) was performed to treat the complete occlusion of previously placed stent in mid rca extending to distal rca.However, the revascularization failed and the residual stenosis was 100%.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that there was a restenosis of the previously placed study stents in mid rca and distal rca.Since the revascularization was unsuccessful, medical treatment was optimized.The patient was already on heart failure and antihypertensive therapy which was intensified with the addition of a loop diuretic.Also, there was an increased risk of stroke after the onset of atrial fibrillation (treated by electrocardioversion) for which oral anticoagulation treatment with apixaban (2 x 5 mg/day) was started.

• 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: 5511853
• MDR Text Key: 40726404
• Report Number: 2134265-2016-01524
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2012
• Device Model Number: H7493911332270
• Device Catalogue Number: 39113-3227
• Device Lot Number: 13990729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2011
• 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: 75 YR