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

Model Number H7493918428270

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

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 07/11/2016

Event Type  Death  

Manufacturer Narrative

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

It was reported that the patient died.The patient was surviving with the left anterior descending artery (lad) the other 2 arteries were infracted and while opening lad the patient had cardiac arrest.The patient was referred for coronary artery bypass grafting as the physician considered this a complex case of multi vessel angioplasty; however the patient declined the referral and physician decided to perform percutaneous transluminal coronary angioplasty.Vascular access was obtained via the femoral artery.The 95% stenosed, 20mm in length, concentric, de novo target lesion was located in the mildly tortuous, mildly calcified, and 2.75mm in diameter mid left anterior descending (lad) artery.The physician planned to open the lad first, followed by right coronary artery (rca) and then in the left circumflex (lcx) artery.A 2.75x28mm promus element(tm) plus drug-eluting stent was advanced and deployed in the lesion.However, post stent deployment; there was slow flow, followed by no flow, and ventricular tachycardia (vt).After the patient became stable, it was decided to open other arteries later.After some time, the patient died in the intensive care unit (icu).

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5844507
• MDR Text Key: 51108930
• Report Number: 2134265-2016-06792
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2017
• Device Model Number: H7493918428270
• Device Catalogue Number: 39184-2827
• Device Lot Number: 18325506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2015
• 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): Death
• Patient Age: 58 YR