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

Model Number H7493918432350

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

Patient Problems Death (1802); Cardiogenic Shock (2262)

Event Date 09/25/2017

Event Type  Death  

Manufacturer Narrative

Device is combination product.Device evaluated by mfr: the complaint device was not received for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specifications.The most probably root cause was unable to be determined.(b)(4).

Event Description

It was reported that the patient died.The patient presented with acute anterior wall myocardial infarction.Vascular access was obtained via the femoral artery.The eccentric, 32x3.5mm target lesion was located in a mildly calcified, moderately tortuous, left circumflex artery.Following predilitation, a 3.5x32mm promus element plus stent was introduced.Significant resistance was encountered while advancing but the stent was deployed.The patient's status was stable post procedure but within the next two hours the patient succumbed to cardiogenic shock.

• 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: 6945982
• MDR Text Key: 89190565
• Report Number: 2134265-2017-10001
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2019
• Device Model Number: H7493918432350
• Device Catalogue Number: 39184-3235
• Device Lot Number: 20249193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR