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

Model Number H7493925138270

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Reocclusion (1985); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 01/29/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that stent thrombosis also occurred on (b)(6) 2015.

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

It was reported that the patient experienced st elevation, stent restenosis and expired. The patient presented to the emergency room with chest pain on (b)(6) 2015 and was diagnosed with an st elevated myocardial infarction (stemi). Cardiac catheterization was initiated at 13:45 and 100% stenosis of the left anterior descending (lad) artery was noted. A 2. 75x38 mm promus premier¿ stent was implanted in the lad followed by dilation with a balloon. The surgery was considered successful and the st levels declined at 14:50. The patient continued to experience chest tightness and a ecg was performed the following day, which showed as q wave (v2-6) with st elevation. The surgeon suggested to performed additional cardiac catheterization; however the patient's family declined. The patient was transferred to another hospital. Treatment with antiplatelet drug, heparin and nitroglycerin was provided and the patient didn't feel chest tightness temporarily. St elevation was again noted and cardiac catheterization was performed, and there was 100% restenosis of the lad. A balloon was then used to place the intra-aortic balloon pump (iabp), however the patient had respiratory failure and was placed on a tracheal tube on (b)(6). On (b)(6) cardiac catheterization was performed and a 3. 0x30 mm and 3. 5x30 mm non-bsc stent were implanted resulting in timi iii flow. However iabp was again placed on (b)(6). The patient was not very stable. Patient experienced pulseless ventricular tachycardia and received electric shock at 02:40 on (b)(6), then had pulseless electrical activity at 12:14, and the patient had expired.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6849114
• MDR Text Key: 101312673
• Report Number: 2134265-2017-09162
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/04/2015
• Device Model Number: H7493925138270
• Device Catalogue Number: 39251-3827
• Device Lot Number: 0017045387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/07/2017 Patient Sequence Number: 1