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

Model Number	H7493952816400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in a coronary artery.A 4.00x16mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the stent separated from the delivery system inside the guide catheter.The delivery system was pulled out and they were able to get the stent out as well.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found that proximal stent struts appeared slightly squashed and flattened.The distal stent od (outer diameter) was measured and was within the maximum crimped stent profile.The distal edge of the bumper tip of the device showed signs of damage.This type of damage is consistent with excessive force being applied to the delivery system.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were tightly wrapped and evenly folded.However, there was evident medium noted inside the balloon resembling dried blood.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found that the device was broken 6.6cm distal of hypotube/mid-shaft bond; a twist in extrusion on proximal side of port exchange and another twist in the inner extrusion 2mm distal of bi-component bond were also noted.The bi-component bond showed no signs of damage or strain.This type of damage is consistent with excessive force being applied to the delivery system.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 cause of the reported difficulties may be due interaction with another device.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in a coronary artery.A 4.00x16mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the stent separated from the delivery system inside the guide catheter.The delivery system was pulled out and they were able to get the stent out as well.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6262182
• Report Number: 2134265-2017-00047
• Device Sequence Number: 19067201
• Product Code: NIQ
• UDI-Device Identifier: 08714729844754
• UDI-Public: (01)08714729844754(17)20171109(10)19287587
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/28/2016

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: 11/09/2017
• Device Model Number: H7493952816400
• Device Catalogue Number: 39528-1640
• Device Lot Number: 19287587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1