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

Model Number	H7493952820220
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product. (b)(4).A fg promus premier us mr 2.25x20mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified proximal stent damage.The proximal end of the stent was bunched distally along the balloon.The od (outer diameter) of the undamaged crimped stent was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube identified a multiple kinks along the hypotube.A visual and tactile examination of the shaft polymer extrusion found no issues.A visual and microscopic examination found that there was no damage to the tip.No other issues were identified during the product analysis.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
Event or Problem Description
Reportable based on device analysis completed on 22-oct-2017.It was reported that crossing difficulties were encountered.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified circumflex artery.A 2.25x20mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a 2.25x16mm stent.No patient complications were reported and the patient's status was fine.However, returned device analysis revealed proximal stent damage.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7000365
• Report Number: 2134265-2017-10935
• Device Sequence Number: 1354106
• Product Code: NIQ
• UDI-Device Identifier: 08714729844761
• UDI-Public: 08714729844761
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/22/2017

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: 06/12/2018
• Device Model Number: H7493952820220
• Device Catalogue Number: 39528-2022
• Device Lot Number: 20093530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2017
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR