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

Model Number 9588

Device Problem Defective Device (2588)

Patient Problems Death (1802); Thrombosis (2100)

Event Date 12/06/2019

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

Same case as mdr: (b)(4) and (b)(4).It was reported that stent profile problem occurred and patient experienced acute thrombosis and died.The highly calcified target lesion was located in the left anterior descending artery (lad).After crossing the lesion with an unspecified guidewire, two unspecified balloon catheters were advanced with difficulty due to the calcification.A 2.5x38mm promus premier drug-eluting stent (des) was implanted in the mid lad.Following implant, a distal dissection was noted along with 18mm of disease that also needed to be treated.A 3.5x32mm promus premier des was proximally overlapped the initially placed stent.Another 2.5x32mm promus premier was advanced distally through both stents but would not deliver despite pushing hard.The device was removed and the lesion was dilated with an unspecified balloon catheter.The 2.5x32mm stent was readvanced but was still unsuccessful.The device was removed however, the stent started stripping off the balloon and accordioned inside the previous deployed stents.The physician attempted to removed the dislodged stent that became stuck in the proximal lad.The artery started to clot after 30 minutes and a ventricular support device was placed.The surgeon was called for surgery but the patient passed away before the procedure.

• Brand Name: PROMUS PREMIER
• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9474802
• MDR Text Key: 170926981
• Report Number: 2134265-2019-15748
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844952
• UDI-Public: 08714729844952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 9588
• Device Catalogue Number: 9588
• Device Lot Number: 0023611667
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• 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: 79 YR