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

Model Number H7493952820300

Device Problem Occlusion Within Device (1423)

Patient Problems Dyspnea (1816); Ischemia (1942); Reocclusion (1985); Ventricular Tachycardia (2132)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2015, clinical assessment indicated that the patient's qualifying conditions stress test strongly positive with severe st depression in the recovery phase, and the medical history of coronary artery disease with prior percutaneous coronary intervention (pci) and coronary artery bypass graft (cabg.On the same day the patient underwent elective percutaneous coronary intervention (pci).The target lesion was a de novo lesion located in the left main coronary artery (lmca) with 99% stenosis.It involved the left circumflex (lcx).It was 18mm long, with a reference vessel diameter of 3.0mm.The thrombolysis in myocardial infarction (timi) flow was 0.The target lesion was treated with pre-dilatation with a 2.5mm balloon at 18 atmospheres and insertion of a 3.00x20mm promus premier everolimus-eluting platinum chromium coronary stent.Post-dilatation was not performed.There was 0% residual stenosis and the timi flow was improved to 3.The following day, the patient subject was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient was diagnosed with 99% in stent restenosis when the patient experienced shortness of breath, silent ischemia, non-sustained ventricular tachycardia, and inferoseptal and anterior wall hypokinesis, with nuclear exercise stress testing.Oxygen saturation on room air was 99%.There was no peripheral edema and no wheezes or rales.The patient underwent pci of the target lesion at the ostium of the lcx.Pre-dilatation was performed with a 3x10mm sculpting balloon, followed by insertion of a 3.0x22mm non bsc drug eluting stent (des).It was deployed at 16 atmospheres.Post dilatation was performed with a 3.5mm high-pressure balloon (hpb).The post-procedural stenosis was 0%.The re-stenting was successful, without complication and post-treatment timi flow was 3.On the same day, the event was considered resolved the patient was discharged.

• Brand Name: PROMUS PREMIER¿
• 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: 5646833
• MDR Text Key: 44992594
• Report Number: 2134265-2016-03985
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2016
• Device Model Number: H7493952820300
• Device Catalogue Number: 39528-2030
• Device Lot Number: 17245108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2014
• 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: 71 YR