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

Model Number	9585
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment inside patient occurred.The target lesion was located in the lower left leg.A 3.00x20mm promus premier drug-eluting stent was advanced for treatment.However, during the procedure, the stent came off of the delivery system before it was deployed.The stent had to be crashed against the wall in the external iliac artery.The procedure was completed with a different device.No further patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: promus premier, us, mr 3.00 x 20 mm stent delivery system was returned for analysis without the polymer extrusion shaft, stent or balloon.The stent was not returned for analysis.The stent outer diameter at the time of manufacturing was within maximum crimped stent profile measurement.The balloon was not returned for analysis.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found a break 118.5cm distal to the distal end of the strain relief, close to the port bond site, leaving the corewire exposed.The portion of the polymer extrusion shaft distal to the port bond, with the balloon and stent, was not returned for analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgment inside patient occurred.The target lesion was located in the lower left leg.A 3.00x20mm promus premier drug-eluting stent was advanced for treatment.However, during the procedure, the stent came off of the delivery system before it was deployed.The stent had to be crushed against the wall in the external iliac artery.The procedure was completed with a different device.No further patient complications were reported and the patient was fine.It was further reported that the device broke and endo-trashed in the artery.

• 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: 8677151
• Report Number: 2134265-2019-06262
• Device Sequence Number: 2358687
• Product Code: NIQ
• UDI-Device Identifier: 08714729844792
• UDI-Public: 08714729844792
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/01/2019

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: 02/26/2020
• Device Model Number: 9585
• Device Catalogue Number: 9585
• Device Lot Number: 0022612619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/01/2019
• 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: Required Intervention
• Patient Age: 72 YR