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

Model Number H7493952838250

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Torn Material (3024)

Patient Problems Death (1802); Device Embedded In Tissue or Plaque (3165)

Event Date 10/03/2017

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

It was reported a balloon tear, stent entrapment, and stent dislodgement occurred.The patient experienced in-stent restenosis of an unknown stent, previously placed in the circumflex.During a procedure to address the restenosis, information suggested a balloon was inflated in the previously placed stent prior to advancing the 2.5 x 38 mm promus premier¿ drug-eluting stent.However, the stent delivery system was only able to advance halfway through the previously placed stent, and the promus premier¿ was then stuck in the previously placed stent.The physician attempted to remove the stent delivery system, but it was not able to be removed.A snare was used in an attempt to remove the stent and delivery system; however, during removal, a distal portion of the balloon tore off and the stent dislodged and fell into the aorta.The patient underwent surgery, during which the stent was retrieved from the aorta and the original procedure was completed.The balloon fragment remained stuck in the circumflex; that area of the circumflex was bypassed during surgery.The patient survived surgery, but died a number of hours following the procedure.The cause of death was not known.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6987232
• MDR Text Key: 90559328
• Report Number: 2134265-2017-10398
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729845003
• UDI-Public: 08714729845003
• 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: Physician
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2019
• Device Model Number: H7493952838250
• Device Catalogue Number: 39528-3825
• Device Lot Number: 21010858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• 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; Required Intervention