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

Model Number	H7493952820400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.A 4.00x20mm promus premier¿ stent was advanced for treatment and was successfully deployed.However, when the stent delivery system was removed post-stent deployment, it was noted that the shaft was broken.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that shaft break occurred.A 4.00x20mm promus premier¿ stent was advanced for treatment and was successfully deployed.However, when the stent delivery system was removed post-stent deployment, it was noted that the shaft was broken.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: promus premier us mr 2.25 x 32mm stent delivery system was returned for analysis.The stent was not returned as it was deployed during the procedure.The balloon was examined; the balloon folds were opened.The balloon appeared to have been inflated and deflated.The distal end of the balloon appeared to be bunched.A leak test was carried out: the balloon was inflated to rated burst pressure, there were no issues with the inflation.There were no leaks noted in the device.A vacuum was pulled and the balloon deflated fully in 3s, which is within the specified time.A visual and tactile examination of the device found multiple hypotube kinks.An examination of the shaft polymer extrusion identified a bunch in the inner shaft polymer extrusion at 2mm distal of the bi-component bond.The tip was visually examined and no issues were noted.No other issues were identified during the product analysis.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7574828
• Report Number: 2134265-2018-05042
• Device Sequence Number: 19337668
• Product Code: NIQ
• UDI-Device Identifier: 08714729844815
• UDI-Public: 08714729844815
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/16/2018

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 Expiration Date: 07/07/2019
• Device Model Number: H7493952820400
• Device Catalogue Number: 39528-2040
• Device Lot Number: 21591845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 06/16/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR