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

Model Number	H7493925212400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the distal right coronary artery (rca).A 12 x 4.00 promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.During removal of the undeployed stent, the device came off the stent delivery system (sds) inside the touhy.The physician removed the dislodged stent with his fingers.Another promus premier¿ drug-eluting stent was advanced but still failed to cross the lesion.Then the physician decided to stop the stenting in the distal rca lesion and performed percutaneous coronary intervention of proximal rca lesion.Subsequently, a stent was successfully implanted at the proximal rca and the procedure was completed.No patient complications were reported and the patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.The stent was dislodged/detached from the sds.There were stent struts throughout the stent that were damaged.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon showed evidence of being inflated as there was contrast in the balloon.The bumper tip was damaged.A visual and tactile examination found no issues with the hypotube shaft profile.A visual and tactile examination of the shaft polymer extrusion found no issues with the profile.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the distal right coronary artery (rca).A 12 x 4.00 promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.During removal of the undeployed stent, the device came off the stent delivery system (sds) inside the tuohy.The physician removed the dislodged stent with his fingers.Another promus premier¿ drug-eluting stent was advanced but still failed to cross the lesion.Then the physician decided to stop the stenting in the distal rca lesion and performed percutaneous coronary intervention of proximal rca lesion.Subsequently, a stent was successfully implanted at the proximal rca and the procedure was completed.No patient complications were reported and the patient's status was good.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6133105
• Report Number: 2134265-2016-10619
• Device Sequence Number: 786617
• Product Code: NIQ
• UDI-Device Identifier: 08714729828846
• UDI-Public: (01)08714729828846(17)20170412(10)18544988
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/02/2016

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: 04/12/2017
• Device Model Number: H7493925212400
• Device Catalogue Number: 39252-1240
• Device Lot Number: 18544988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR