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

Model Number	H7493952824270
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 2.75x24mm promus premier drug-eluting stent was selected to treat the lesion.During preparation, upon loading the device, it was noted that the stent had kinks.The device did not enter the patient's body.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.A 2.75x24mm promus premier¿ drug-eluting stent was selected to treat the lesion.During preparation, upon loading the device, it was noted that the stent had kinks.The device did not enter the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: promus premier us mr 2.75 x 24mm stent delivery system was returned for analysis.The entire stent was damaged and had moved in a distal direction on the balloon with struts stretched over the distal tip of the device.The manufacturing crimp data for this device was reviewed and there were no anomalies noted.The maximum stent outer diameter was within max crimped stent profile measurement.No issues with the balloon.There were crimp markings evident on the exposed balloon wall indicating crimp contact between the balloon and the stent at the time of manufacture.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the device found multiple hypotube kinks.An examination of the shaft polymer extrusion revealed 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 manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Additional Manufacturer Narrative
Device evaluated by mfr.: promus premier us mr 2.75 x 24mm stent delivery system was returned for analysis.The entire stent was damaged and had moved in a distal direction on the balloon with struts stretched over the distal tip of the device.The manufacturing crimp data for this device was reviewed and there were no anomalies noted.The maximum stent outer diameter was within max crimped stent profile measurement.No issues with the balloon.There were crimp markings evident on the exposed balloon wall indicating crimp contact between the balloon and the stent at the time of manufacture.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the device found multiple hypotube kinks.An examination of the shaft polymer extrusion revealed 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 manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 2.75x24mm promus premier¿ drug-eluting stent was selected to treat the lesion.During preparation, upon loading the device, it was noted that the stent had kinks.The device did not enter the patient's body.No patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7317270
• Report Number: 2134265-2018-01613
• Device Sequence Number: 11126666
• Product Code: NIQ
• UDI-Device Identifier: 08714729844846
• UDI-Public: 08714729844846
• Combination Product (Y/N): N
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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: 02/15/2018
• Device Model Number: H7493952824270
• Device Catalogue Number: 39528-2427
• Device Lot Number: 19638285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR