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

Model Number	H7493952812400
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: 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 catheter entrapment and shaft break occurred.The target lesion was located in a coronary artery.After crossing a wire to the lesion, a 4.00x12mm promus premier¿ stent was advanced but became stuck with the wire at about 10 cm proximal to the guide catheter.The device was attempted to be removed; however it would not come off the wire.Moreover, the shaft got separated 10-15 cm from the hub upon pulling the device really hard.Subsequently, both the promus stent and the wire were removed together.The procedure was completed with another wire and another stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the proximal portion which includes the hypotube and the manifold was not returned with the stent delivery system.The distal portion was returned froze onto the 0.0135¿¿guidewire.A visual examination of the crimped stent identified no issues.The stent showed no signs of damage or movement and was set equidistant between the proximal and distal markerbands.The crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.An enquiry into the return of the hypotube section was made, however it was not returned for analysis.A visual and tactile examination found a midshaft break 25mm proximal from the skive.An attempt was made to remove the guidewire however it was not possible.There were multiple kinks to inner and outer extrusions, the inner was damaged (compression failure) 2mm distal from bi-component bond.The bi-component bond showed no signs of damage or strain.Based on the event description and analysis results the damaged noted to the returned section of the device most likely occurred due to excessive force used while trying to remove the stent off the guidewire.The distal portion of the device froze onto the wire due to the damaged noted on the inner extrusion.A visual and tactile examination found no damage to the tip.No other issues were identified during the product analysis.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 catheter entrapment and shaft break occurred.The target lesion was located in a coronary artery.After crossing a wire to the lesion, a 4.00x12mm promus premier¿ stent was advanced but became stuck with the wire at about 10 cm proximal to the guide catheter.The device was attempted to be removed; however it would not come off the wire.Moreover, the shaft got separated 10-15 cm from the hub upon pulling the device really hard.Subsequently, both the promus stent and the wire were removed together.The procedure was completed with another wire and another stent.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: 7116278
• Report Number: 2134265-2017-12539
• Device Sequence Number: 11136748
• Product Code: NIQ
• UDI-Device Identifier: 08714729844693
• UDI-Public: 08714729844693
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/04/2017

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: Physician
• Device Expiration Date: 07/19/2018
• Device Model Number: H7493952812400
• Device Catalogue Number: 39528-1240
• Device Lot Number: 0020210900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1