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

Model Number	H7493952808300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a right coronary artery.A 3.00x8mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the stent came off the delivery balloon prematurely.A snare was then used to capture the stent from the artery.The procedure was completed with another promus premier¿ drug-eluting stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the promus premier mr, us, 3.0x8mm stent delivery system (sds) was returned.The stent was not returned on the device as it came off the balloon prematurely during the procedure.The stent outer diameter is measured and verified against specification for the product prior to packaging and shipping.A review of the promus premier, manufacturing crimp data for the returned device was performed.The balloon cones were reviewed and no issues were noted.Balloon wings were in original folded position.Crimp stent markings were evident on the exposed proximal portion of the balloon wall, indicating that there was crimp contact between the coated stent and balloon at the time of manufacture.A visual and tactile examination found several hypotube along the full catheter length.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.A visual examination found no tip damage.No other issues were identified during the product analysis.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a right coronary artery.A 3.00x8mm promus premier drug-eluting stent was advanced to treat the lesion.However, the stent came off the delivery balloon prematurely.A snare was then used to capture the stent from the artery.The procedure was completed with another promus premier drug-eluting stent.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7299236
• Report Number: 2134265-2018-01323
• Device Sequence Number: 13765526
• Product Code: NIQ
• UDI-Device Identifier: 08714729844617
• UDI-Public: 08714729844617
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 02/02/2018

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: 09/24/2018
• Device Model Number: H7493952808300
• Device Catalogue Number: 39528-0830
• Device Lot Number: 0020483279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 03/26/2018
• 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: Required Intervention