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

Model Number	H7493952824250
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
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 occurred.The target lesion was located in the tortuous left anterior descending artery (lad).After rotablation was performed and a 2.50x16mm stent was implanted, a 2.50x24mm promus premier¿ drug-eluting stent was advanced; however, a lot of resistance was encountered.The device was removed from the patient's body and the tip was noted to be a little bit flared out.The procedure was completed with another 2.50x24mm promus premier¿ drug-eluting stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: promus premier us mr 2.50 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent identified distal stent damage.Strut 1 from the distal end of the stent was pulled in a distal direction.The remainder of the stent was undamaged.The crimped stent od(outer diameter) of the undamaged section was measured and was within max 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.A visual and tactile examination of the hypotube found no issues.An examination of the inner and outer shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.There were no issues advancing the device over a 0.014¿ guidewire.The tip was visually examined and no issues were noted.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 is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the tortuous left anterior descending artery (lad).After rotablation was performed and a 2.50x16mm stent was implanted, a 2.50x24mm promus premier¿ drug-eluting stent was advanced; however, a lot of resistance was encountered.The device was removed from the patient's body and the tip was noted to be a little bit flared out.The procedure was completed with another 2.50x24mm promus premier¿ drug-eluting stent.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: 6673099
• Report Number: 2134265-2017-06501
• Device Sequence Number: 16637372
• Product Code: NIQ
• UDI-Device Identifier: 08714729844839
• UDI-Public: (01)08714729844839(17)20180521(10)0020029341
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/13/2017

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: 05/21/2018
• Device Model Number: H7493952824250
• Device Catalogue Number: 39528-2425
• Device Lot Number: 0020029341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1