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

Model Number	H7493952812300
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Promus premier mr, ous, 3.0x12mm, stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found no issues with the crimped stent.There were no signs of damage; stretching or lifting of the stent struts.The stent od (outer diameter) was measured and was within the maximum crimped stent specification indicating that there were no issues with the crimp stent profile.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 found a hypotube break 256mm distal to distal end of strain relief.There were also multiple kinks found along the hypotube.A visual and tactile examination found no issue with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found damage to the tip.The type of damage evident is consistent with resistance being encountered during advancement.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 considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 08-aug-2017.It was reported that shaft damage occurred.The target lesion was located in a coronary artery.A 3.00x12mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during delivery, it was noted that the shaft was damaged.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hypotube break.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6824741
• Report Number: 2134265-2017-08410
• Device Sequence Number: 19193451
• Product Code: NIQ
• UDI-Device Identifier: 08714729844679
• UDI-Public: (01)08714729844679(17)20180826(10)20368309
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 08/08/2017

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: 08/26/2018
• Device Model Number: H7493952812300
• Device Catalogue Number: 39528-1230
• Device Lot Number: 20368309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1