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

Model Number	H7493952828250
Medical Device Problem Codes	Bent (1059); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage and stent move on balloon occurred.A 2.50x28mm promus premier¿ drug eluting stent was selected for use.However during the procedure, the stent was noted to be flared and partially pulled off from the stent delivery system.The procedure was completed with another stent.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: a distal portion of a stent delivery system (sds), device tip to break site in the mid-shaft, was returned for analysis with a stent on the balloon, the portion of the sds distal of the mid-shaft break site (including the hypotube, strain relief and manifold) was not returned for analysis.A visual and microscopic examination of the crimped stent found proximal stent damage.Proximal stent struts were bunched along the balloon in a distal direction and flared outwards.The undamaged portion of the crimped stent od (outer diameter) was measured and is within maximum crimped stent profile measurement.The balloon cone wings were folded and were not subjected to positive pressure.Crimp markings were evident on exposed balloon wall, exposed by stent bunching and flaring, indicating correct positioning and crimping of stent prior to the complaint incident.A visual and tactile examination of the shaft polymer extrusion found a shaft polymer extrusion kink 4.5mm distal of bi-component bond.A break was noted in the mid-shaft section, 4.6cm proximal of port bond site.A visual and microscopic examination found that there was 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 was unable to be determined.(b)(4). .
Event or Problem Description
It was reported that stent damage and stent move on balloon occurred.A 2.50x28mm promus premier¿ drug eluting stent was selected for use.However during the procedure, the stent was noted to be flared and partially pulled off from the stent delivery system.The procedure was completed with another stent.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6304054
• Report Number: 2134265-2017-00598
• Device Sequence Number: 13652483
• Product Code: NIQ
• UDI-Device Identifier: 08714729844891
• UDI-Public: (01)08714729844891(17)20170910(10)19073181
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/16/2017

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: 09/10/2017
• Device Model Number: H7493952828250
• Device Catalogue Number: 39528-2825
• Device Lot Number: 19073181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1