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

Model Number H7493911338300

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Pain (1994); Thrombosis (2100)

Event Date 06/13/2014

Event Type  Injury  

Event Description

Same case as mdr id# 2134265-2015-03666, 2134265-2015-03667 and 2134265-2015-03669.(b)(4).It was reported that very late stent thrombosis occurred.In (b)(6) 2013, the patient was referred for cardiac catheterization which revealed four (4) target lesions.Target lesion #1 was located in the proximal right coronary artery (rca) extending into distal rca with 75% stenosis, and was 28mm long with a reference vessel diameter of 4.0 mm.Target lesion #1 was treated with pre-dilatation and placement of a 4.00 x 28mm study stent.Following intervention, residual stenosis was 0%.Target lesion #2 was located in the proximal rca extending into distal rca with 80% stenosis, and was 32mm long with a reference vessel diameter of 4.0 mm.Target lesion #2 was treated with pre-dilatation and placement of a 4.00 x 32mm study stent.Following intervention, residual stenosis was 0%.Target lesion #3 was located in the proximal rca extending into distal rca with 100% stenosis, and was 38mm long with a reference vessel diameter of 3.0mm.Target lesion #3 was treated with pre-dilatation and placement of 3.00 x 38mm study stent.Following intervention, residual stenosis was 0%.Target lesion #4 was located in the proximal rca extending into distal rca with 100% stenosis, and was 24mm long with a reference vessel diameter of 2.5mm.Target lesion #4 was treated with pre-dilatation and placement of 2.50 x 24mm study stent.Following intervention, residual stenosis was 0%.Seven days post index procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented with cardiac pain and was hospitalized.Four days post admission, coronary angiography revealed 80% stent thrombosis of the previously placed study stent from the proximal rca to the distal rca.On the same day, the patient was treated with percutaneous coronary intervention (pci).Following intervention, residual stenosis was 0%.Two days post intervention the event was considered as recovered/resolved and the patient was discharged on the same day.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that on (b)(6) 2015, in-stent restenosis occurred and was not stent thrombosis as what was previously reported.

• Brand Name: PROMUS ELEMENT ¿ LONG
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4824789
• MDR Text Key: 5904528
• Report Number: 2134265-2015-03668
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2015

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: 06/14/2014
• Device Model Number: H7493911338300
• Device Catalogue Number: 39113-3830
• Device Lot Number: 15808649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/08/2015
• Supplement Dates Manufacturer Received: 09/19/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR