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

Model Number H7493911432220

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Dyspnea (1816); Fatigue (1849); Reocclusion (1985)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

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)(6) clinical study.It was reported that angina and in-stent restenosis (isr) occurred.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was stable angina and the patient was for cardiac catheterization.Subsequently, index procedure and coronary angiography were performed.The target lesion was located in the mid left anterior descending (lad) with 80% stenosis and was 26mm long with a reference vessel diameter of 2.25mm.The lesion was treated with pre-dilatation and placement of a 2.25x32/38mm study stent with 0% residual stenosis.On the same day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient presented with recurrent chest discomfort, dyspnea and fatigue with class ii congestive heart failure (chf).Subsequently, the patient was diagnosed with recurrent angina and cardiac catheterization was recommended.In (b)(6) 2016, coronary angiography was performed and revealed a 40-50% proximal-mid stenosis and 80% focal eccentric mid stenosis at the prior study stent site.Subsequently, the 50-80% (isr) located in mid lad was treated with the placement of 2.25x8mm non-bsc stent with 0% residual stenosis.On the same day, the event considered to be resolved.

Manufacturer Narrative

Event date corrected from (b)(6) 2016 to (b)(6) 2016.(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the patient was also suspected with progression of coronary artery disease (cad).In (b)(6) 2016, the patient presented for cardiac catheterization with percutaneous coronary intervention (pci) and the in-stent restenosis (isr) located in the mid left anterior descending artery was 70-79% and not 50-80% as previously reported.On the same day, follow-up core-lab angiography of mid left anterior descending (lad) was performed and revealed absence of thrombus as well as aneurysm.However, core lab noted the presence of isr pattern 1c.Revascularization included target lesion revascularization (tlr).

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5853044
• MDR Text Key: 51351154
• Report Number: 2134265-2016-06873
• 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: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2013
• Device Model Number: H7493911432220
• Device Catalogue Number: 39114-3222
• Device Lot Number: 15547728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: 61 YR