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

Model Number	H7493952838400
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that premature deployment of stent occurred.A 4.00x38mm promus premier¿ was selected to treat the lesion.However, upon removing the device out of the box, it was noted that the stent was unwound on the wire and expanded.The device was not inserted into the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier, mr, us 4.0 x 38mm stent delivery system (sds) was returned for analysis.A visual examination found distal struts stretched and pulled distally.The stent outer diameter (od) of the undamaged proximal section was measured and is within the maximum crimped stent specification.The balloon cones were reviewed and no issues were noted.The stent crimp force, the crimp temperature and the crimped stent profile for the device all are within the specified range.The product stent protector was not returned for analysis with the device, however the specified inside diameter of the stent protector (id) and the max crimped stent profile for this device shows there is no issues to note with the interaction between the two components.A visual and tactile examination found multiple kinks along the full catheter length.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issues with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found no damage to the tip.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 most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that premature deployment of stent occurred.A 4.00x38mm promus premier¿ was selected to treat the lesion.However, upon removing the device out of the box, it was noted that the stent was unwound on the wire and expanded.The device was not inserted into 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: 6175367
• Report Number: 2134265-2016-11527
• Device Sequence Number: 16253340
• Product Code: NIQ
• UDI-Device Identifier: 08714729845041
• UDI-Public: (01)08714729845041(17)20170507(10)18623298
• 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,Followup
• Report Date (Section B): 11/28/2016

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: 05/07/2017
• Device Model Number: H7493952838400
• Device Catalogue Number: 39528-3840
• Device Lot Number: 18623298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1