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

Model Number 9315

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 06/27/2019

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that sudden cardiac arrest and death occurred. Vascular access was obtained via the femoral artery. A percutaneous transluminal coronary angioplasty (ptca) was performed on an 80% stenosed target lesion in the non calcified, non tortuous left anterior descending artery (lad) and obtuse marginal (om). Following predilatation, a 3. 00 x 38mm promus element long was deployed in the distal lad, a 3. 50 x 16mm promus element was deployed in the proximal lad, and a 3. 00 x 24mm promus element was deployed in the om. After three hours of ptca, the patient had sudden cardiac arrest and died in the coronary care unit (ccu) due to a reason unknown.

• Brand Name: PROMUS ELEMENT LONG
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8754293
• MDR Text Key: 149826147
• Report Number: 2134265-2019-07669
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/25/2020
• Device Model Number: 9315
• Device Catalogue Number: 9315
• Device Lot Number: 0022752629
• 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: 07/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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: 07/02/2019 Patient Sequence Number: 1