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

Model Number	H7493952838250
Medical Device Problem Codes	Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Torn Material (3024)
Health Effect - Clinical Codes	Death (1802); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/03/2017
Type of Reportable Event	Death
Additional 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 or Problem 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¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6987232
• Report Number: 2134265-2017-10398
• Device Sequence Number: 488692
• Product Code: NIQ
• UDI-Device Identifier: 08714729845003
• UDI-Public: 08714729845003
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/30/2017
• 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; Required Intervention