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

Model Number H7493911412350

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Reocclusion (1985); Dizziness (2194); Palpitations (2467)

Event Date 03/22/2016

Event Type  Injury  

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).

Event Description

Same case as mdr id 2134265-2016-03116.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient was diagnosed with unstable angina and was subsequently referred for cardiac catheterization.On the same day, index procedure was performed.Target lesion #1 was located in the distal saphenous vein graft (svg) to right posterior descending artery segment (r-pda) with 90% isr (unknown drug-eluting stent) and was 42mm long with a reference vessel diameter of 3.6mm.Target lesion #1 was treated with direct stent placement using 3.50 x 38 mm and 3.50 x 12 mm pe plus study stents in overlapping manner.Following post-dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented with complaints of chest pain that starts in her back and radiates to chest and both arms, lasting a few minutes, and relieved with nitroglycerin.The patient also complaints of dyspnea, fatigue, palpitations and dizziness.Subsequently, the patient was referred for cardiac catheterization.The following day, coronary angiography revealed 98% distal stenosis on svg to r-pda and 75% proximal stenosis (isr of study stents).Percutaneous coronary intervention (pci) was performed in the distal svg to r-pda to treat 98% stenosis, with 0% residual stenosis.Additionally, pci was performed in the proximal svg to r-pda to treat 75% stenosis, with 0% residual stenosis.One day post procedure, the event was considered resolved and the patient was discharged on aspirin.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the 98% in-stent restenosis (isr) in the distal saphenous vein graft (svg) to right posterior descending artery (r-pda) was treated with the placement of 4.00 x 24mm promus premier stent.Following post-dilation, residual stenosis was 0% with timi 3 flow.The 75% lesion in the proximal svg to r-pda was treated with the placement of 4.00 x 38mm promus premier stent.Following post-dilatation, residual stenosis was 0% with timi 3 flow.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 5587417
• MDR Text Key: 43013804
• Report Number: 2134265-2016-03117
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

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: 12/05/2013
• Device Model Number: H7493911412350
• Device Catalogue Number: 39114-1235
• Device Lot Number: 0015779636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• 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: 74 YR