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

Model Number	H7493952838300
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the promus premier us mr 3.00 x 38 mm stent delivery system was returned for analysis.The stent was detached from the sds and was not returned for analysis.There were no issues reported with the stent.The balloon wings were relaxed and it appeared the balloon had been inflated and a vacuum pulled.There was hardened contrast medium evident in the balloon body.The device was attached to a handheld encore inflation device without issue.The balloon was inflated to nominal inflation pressure without issue.A visual and tactile examination of the device found multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.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).
Event or Problem Description
Reportable based on device analysis completed on 15-jan-2018.It was reported that connection incompatibility occurred.A 3.00 x 38 mm promus premier¿ drug-eluting stent was selected for use.However, when the stent delivery system (sds) was connected to a bsc inflation device, the sds would not connect securely.The procedure was completed with another 3.0 x 38 mm promus drug-eluting stent.No patient complications were reported.However, returned device analysis revealed a detached/separated stent.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7251278
• Report Number: 2134265-2018-00514
• Device Sequence Number: 13492233
• Product Code: NIQ
• UDI-Device Identifier: 08714729845027
• UDI-Public: 08714729845027
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 01/15/2018

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: 02/13/2019
• Device Model Number: H7493952838300
• Device Catalogue Number: 39528-3830
• Device Lot Number: 0021049307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1