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

Model Number H7493911412220

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 12/19/2017

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.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-13368.(b)(6) study.It was reported that in-stent restenosis (isr) and angina occurred.In (b)(6) 2013, clinical status assessment indicated that the patient¿s qualifying condition was stable angina.The patient was noted to have abnormal stress test or imaging stress test indicative of ischemia and was referred for elective cardiac catheterization.Target lesion #1 was located in the mid left anterior descending (lad) artery with 80% stenosis and was 22mm long with a reference vessel diameter of 3mm.The target lesion #1 was treated with pre-dilatation and placement of a 3.0 x 28mm study stent with 0% residual stenosis.Target lesion #2 was located in the 1st diagonal with 95% stenosis and was 6mm long with a reference vessel diameter of 2.25mm.The target lesion #2 was treated with pre-dilatation and placement of a 2.25 x 12mm study stent with 0% residual stenosis.Target lesion #3 was located in 1st right posterolateral (rpl) with 90% stenosis and was 6mm long with a reference vessel diameter of 2.5mm.The target lesion #3 was treated with pre-dilatation and placement of a 2.50 x 12mm study stent with 0% residual stenosis.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient presented as an outpatient with complaints of chest discomfort and severe fatigue, dyspnea.The patient complained that he was not feeling well in the last few weeks and eventually progression of coronary artery disease (cad) and possible stent restenosis was suspected.The patient was recommended for ischemic evaluation.On that same day, the patient's electrocardiogram (ekg) revealed sinus rhythm, non-specific st changes, low voltages, old inferior myocardial infarction (mi) with q waves.The patient was advised to continue with his medications asa, lopressor, imdur and plavix.Two days after, the 70-80% stenosis in the proximal and mid portion of the lad was treated with a 2.5 x 33mm non-bsc drug-eluting stent (des).Following post-dilatation, residual stenosis was 0%.Additionally, the 80-90% stenosis in the 2nd diagonal was treated with placement of a 2.5 x 8mm non-bsc des.Following post-dilatation, residual stenosis was 0%.On that same day, 80% stenosis in the proximal lcx was treated with placement of a 2.0 x 15mm non-bsc des.Following post-dilatation residual stenosis was 0%.

• 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: 7394724
• MDR Text Key: 104248399
• Report Number: 2134265-2018-03336
• 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
• Report Date: 03/09/2018

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: 10/14/2013
• Device Model Number: H7493911412220
• Device Catalogue Number: 39114-1222
• Device Lot Number: 15689423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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): Other
• Patient Age: 62 YR