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

Model Number	H7493952838400
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified tibioperoneal trunk.A 4.00x38mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the stent was caught on a previously implanted non-bsc stent and was dislodged from the delivery system.The dislodged stent was then post dilated in the popliteal artery and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier us mr 4.00 x 38mm stent delivery system was returned for analysis.The stent was not returned for analysis as it was deployed in the patient during the procedure.The manufacturing data for this device was reviewed and no anomalies were highlighted with the crimp details.The maximum stent profile was within maximum crimped stent profile measurement.The balloon appeared to have been subjected to positive pressure and a vacuum pulled.A visual and tactile examination of the hypotube revealed multiple kinks.An examination of the shaft polymer extrusion revealed multiple kinks.The tip was visually examined and damage was noted.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 60% stenosed target lesion was located in the mildly tortuous and mildly calcified tibioperoneal trunk.A 4.00x38mm promus premier drug-eluting stent was advanced to treat the lesion.However, the stent was caught on a previously implanted non-bsc stent and was dislodged from the delivery system.The dislodged stent was then post dilated in the popliteal artery and the procedure was completed with a different device.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: 7544497
• Report Number: 2134265-2018-04554
• Device Sequence Number: 1453050
• Product Code: NIQ
• UDI-Device Identifier: 08714729845041
• UDI-Public: 08714729845041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: 07/30/2019
• Device Model Number: H7493952838400
• Device Catalogue Number: 39528-3840
• Device Lot Number: 0021722056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 06/18/2018
• 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: Other