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

Model Number	H7493952832250
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-10552.It was reported that during a percutaneous coronary intervention to treat a chronic total occlusion, the stent delivery system stuck to the guide wire and the catheter shaft broke.The calcified target lesion was located in the right coronary artery.The physician was able to cross the lesion and dilate several times with a balloon.A 300cm straight tip samurai guide wire was placed in the distal vessel.A 2.50 x 32mm promus premier¿ drug-eluting stent was advanced, but failed to cross the lesion.Upon removal from the body, the stent delivery system became stuck on the proximal portion of the guide wire.While trying to remove the stent delivery system from the wire, the catheter shaft separated at the wire exit port.All components were outside of the body; no device fragments separated within the patient.There were no patient complications and the lesion was successfully stented with a new 2.5 x 32mm stent.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent and delivery system were received for analysis.A visual examination of the stent found that the stent was damaged along its entire length and was moved in a proximal direction on the balloon, covering the distal balloon cone.Device analysis suggests that all stent struts were intact and no fracture had occurred.A visual and microscopic examination found damage to the distal tip.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.Stent crimp markings were visible on the exposed balloon body indicating that the stent was crimped to the balloon prior to shipping.A visual and tactile examination of the device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the device found a break at the guidewire exchange port exposing the core wire and separating the distal end of the device.Damage was noted to the guidewire exchange port.Damage was noted along the entire length of the polymer extrusion.The distal portion of the device was returned on a section of wire.The wire was measured using snap gauge and measured 0.013¿¿.The distal end of the wire appeared to be broken.An attempt was made to remove the wire; however, i.The device was soaked in a water bath at a temperature of 37 degrees celsius in an attempt to soften any solidified media which may be preventing removal of wire from the wire lumen.After soaking overnight, the section of wire was able to be removed from the device.The distal portion of the device was then tracked over a 0.014¿¿ guidewire.The device was able to track over the wire however some resistance was felt due to the damage along the polymer extrusion.The device most likely froze on the wire due to polymer extrusion damage caused when attempted to cross the lesion.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 operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-10552.It was reported that during a percutaneous coronary intervention to treat a chronic total occlusion, the stent delivery system stuck to the guide wire and the catheter shaft broke.The calcified target lesion was located in the right coronary artery.The physician was able to cross the lesion and dilate several times with a balloon.A 300cm straight tip samurai guide wire was placed in the distal vessel.A 2.50 x 32mm promus premier¿ drug-eluting stent was advanced, but failed to cross the lesion.Upon removal from the body, the stent delivery system became stuck on the proximal portion of the guide wire.While trying to remove the stent delivery system from the wire, the catheter shaft separated at the wire exit port.All components were outside of the body; no device fragments separated within the patient.There were no patient complications and the lesion was successfully stented with a new 2.5 x 32mm stent.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6993212
• Report Number: 2134265-2017-10546
• Device Sequence Number: 16482272
• Product Code: NIQ
• UDI-Device Identifier: 08714729844952
• UDI-Public: 08714729844952
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/10/2017

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: 10/17/2018
• Device Model Number: H7493952832250
• Device Catalogue Number: 39528-3225
• Device Lot Number: 0020576388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR