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

Model Number	9588
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	12/06/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem 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
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9474802
• Report Number: 2134265-2019-15748
• Device Sequence Number: 2649148
• Product Code: NIQ
• UDI-Device Identifier: 08714729844952
• UDI-Public: 08714729844952
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR