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

Model Number H7493911424250

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Chest Tightness/Pressure (2463)

Event Date 11/30/2016

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

(b)(6).It was reported that stent restenosis occurred.In (b)(6) 2013, the patient was diagnosed with unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.Target lesion #1 was a de novo lesion located in the proximal left anterior descending(lad) with 80% stenosis and was 8.00mm long with a reference vessel diameter of 2.50mm.Target lesion #1 was treated with pre-dilation and placement of 2.50x24.00mm promus element¿ plus drug-eluting stent(des).Following post-dilatation, residual stenosis was 0%.Target lesion #2 was a de novo lesion located in the mid lad with 95% stenosis and was 4.00mm long with a reference vessel diameter of 5.00mm.Target lesion #2 was treated with pre-dilation and placement of 3.50x20.00mm promus element plus des.Following post-dilatation, residual stenosis was 0%.Target lesion #3 was a de novo lesion located in the distal lad with 75% stenosis and was 3.00mm long with a reference vessel diameter of 10.00mm.Target lesion #3 was treated with pre-dilation and placement of 3.00x20.00mm promus element plus des.Following post-dilatation, residual stenosis was 0%.The following day, the patient was discharged on aspirin and clopidogrel.In october 2016, the patient presented to the hospital with the complaint of chest pressure and was referred for nuclear stress test which revealed the stress test was abnormal suggestive of apical to mid anteroseptal defect and transthoracic echocardiogram revealed ejection fraction to be 45%.Given these findings, the patient was referred for cardiac catheterization.In (b)(6) 2016, the subject was hospitalized in view of cardiac catheterization due to worsening coronary artery disease (cad).The 90% in-stent restenosis in the mid section of proximal lad, with timi flow 2, was treated with 3.5mmx18mm non-bsc des.Post treatment residual stenosis was 0%.In addition, the 90% stenosis located in proximal left circumflex(lcx) was treated with the placement of a 3.00x18mm non-bsc des and 3.00mmx9mm non-bsc des.During the procedure, positive distal obtuse marginal dissection was noted with good flow.Two days after, the event was resolved and the patient was discharged on the same day.

Manufacturer Narrative

Describe event or problem, relevant tests/lab data updated and corrected.(b)(4).

Event Description

It was further reported that target lesion #1 was located in the distal left anterior descending (lad).Target lesion # 2 was 5.00 mm long with reference vessel diameter of 4.0 mm.Target lesion #3 was located in the proximal lad was 10.00 mm long with a reference vessel diameter of 3.00 mm.

• 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: 6278685
• MDR Text Key: 65767466
• Report Number: 2134265-2017-00372
• 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: 01/06/2017

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: 08/02/2013
• Device Model Number: H7493911424250
• Device Catalogue Number: 39114-2425
• Device Lot Number: 15511281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR