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

Model Number	H7493952838400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Age at time of event: mid 60's.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery (rca).A 4.00x38mm promus premier¿ drug eluting stent was advanced to treat the lesion.However, when the physician noticed that the stent was getting to the end of the guide catheter, the stent got dislodged from the balloon.The physician stopped advancing the stent and started to pull the balloon away from the stent.The physician went back in with a smaller 1.5 balloon and it was inserted through the lumen of the stent.The balloon was inflated and the stent was drawn back out of the patient's body.The procedure was ended at that time and did not continue to fix the rca.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds) including the hypotube, midshaft, shaft polymer extrusion, balloon and tip was not returned for analysis therefore the catheter batch/serial number cannot be identified.A visual examination of the crimped stent found that the stent was detached/separated from the delivery system and returned on a 0.014¿¿ guidewire with a balloon.The stent was damaged and stretched its entire length.The sds was not returned for analysis therefore reviews for individual assessment of the catheter could not be performed.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery (rca).A 4.00x38mm promus premier drug eluting stent was advanced to treat the lesion.However, when the physician noticed that the stent was getting to the end of the guide catheter, the stent got dislodged from the balloon.The physician stopped advancing the stent and started to pull the balloon away from the stent.The physician went back in with a smaller 1.5 balloon and it was inserted through the lumen of the stent.The balloon was inflated and the stent was drawn back out of the patient's body.The procedure was ended at that time and did not continue to fix the rca.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: 7677067
• Report Number: 2134265-2018-06258
• Device Sequence Number: 1370122
• Product Code: NIQ
• UDI-Device Identifier: 08714729845041
• UDI-Public: 08714729845041
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493952838400
• Device Catalogue Number: 39528-3840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1