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

Model Number	UNK758
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: promus premier us mr 3.00 x 20mm stent delivery system was returned for analysis.The stent was not returned for analysis.The balloon appeared to have been subjected to positive and a vacuum pulled.Using a hand-held encore device an attempt was made to inflate the balloon to rated burst pressure (rbp) however the attempt failed due to the hardened medium evident, the device was left to soak in water bath at 37 degrees to soften the hardened medium.After soaking the balloon inflated to rbp with no issue.The balloon was deflated in 3.2 seconds as per direction for use.A visual and tactile examination of the device found multiple hypotube kinks.An examination of the shaft polymer extrusion revealed multiple inner/outer extrusion kinks.There was hardened contrast medium evident in the lumen.There were no issues advancing the device over a 0.014¿ guidewire.The tip was visually examined and no issues were 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 was unable to be determined.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 30-apr-2018.A 3.00x20mm promus premier¿ drug-eluting stent was received with no issues reported.However, upon review of this device, stent detachment/separation occurred.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7540344
• Report Number: 2134265-2018-04440
• Device Sequence Number: 1794424
• Product Code: NIQ
• UDI-Device Identifier: 08714729844792
• UDI-Public: 08714729844792
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: 10/05/2016
• Device Model Number: UNK758
• Device Lot Number: 17987569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1