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

Model Number UNK758

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

Patient Problems Aneurysm (1708); Death (1802); Rupture (2208)

Event Date 12/17/2015

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

Same case as mdr id# 2134265-2015-09341, 2134265-2015-09342, and 2134265-2015-09388.It was reported that the patient died.Intravenous ultrasound (ivus) was performed which revealed a target lesion located in the mid left anterior descending (lad) artery and an aneurysm in the left main trunk (lmt).Following the insertion of a mach 1 / 7fr q3.5sh guide catheter and the advancement of a non-bsc guide wire, a 3.0x38 and 3.5x28 promus premier drug-eluting stents were deployed in the target lesion and a 28 x 4.00 promus premier drug-eluting stent was deployed to treat the aneurysm in the lmt.Ivus was performed and it was noted that the 28 x 4.00 promus premier drug-eluting stent that was not well apposed.Subsequently, a 5.5mm x 15mm maverick xl balloon catheter was advanced to post-dilate the 28 x 4.00 promus premier drug-eluting stent; however, the aneurysm ruptured during the dilatation.A non-bsc balloon catheter was then used to stop the bleeding but failed to do so and the patient went to ventricular fibrillation (vf).The patient was transferred to the intensive care unit (icu) and was treated, but died.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the premier 3.0x38, 3.5x28 stents were implanted without problem.The promus premier 4.0x28 stent was inflated with low pressure in order not to compress the aneurysm.The physician commented that the cause of death was due to the bleeding aneurysm rupture.An autopsy was not performed.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5363313
• MDR Text Key: 35773232
• Report Number: 2134265-2015-09389
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 12/17/2015

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 Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: INFLATION DEVICE: ENCORE 26 BSJ
• Patient Outcome(s): Death
• Patient Age: 78 YR