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

Model Number H7493952816250

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is a combination product.Device evaluated by mfr: the stent delivery system (sds) was returned for analysis without the manifold hub.As a result, the manifold number (catheter number & serial number) cannot be recorded for investigation purposes.A visual and tactile examination found a break in the hypotube shaft just distal from the strain relief (1.43m from the distal edge of the bumper tip) as a result of a severe kink in the hypotube shaft.The hypotube appears to have broke due to the application of excessive force.A review of the in-process vacuum decay test (vdt) for the associated batch was carried out to confirm that no anomalies were present within the batch.A breach/damage/issue with the device delivery catheter (including the manifold/hub) would yield a fail for the tested unit, thus scrapping would be performed.Two scrap units were recorded at the top-assembly process with a top-assembly final pass yield.This is considered a good pass rate for the batch size concerned with no indicators present regarding delivery shaft issues.The bumper tip of the device showed no signs of damage.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.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 showed no signs of movement and was set equidistant between the proximal and distal markerbands.A visual and tactile examination of the outer and mid-shaft section found no issues with their profile.The bi-component bond showed no signs of damage or strain.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 Description

Reportable based on device analysis completed on 10-aug-2015.It was reported that the hub was broken.A 2.50x16mm promus premier stent was selected.During the procedure while still outside the patient's body, the hub of the device broke off from the catheter shaft.The procedure was completed using another of the same device.No patient complications were reported.However, returned device analysis revealed hypotube break.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5054297
• MDR Text Key: 24986599
• Report Number: 2134265-2015-05920
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/10/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2016
• Device Model Number: H7493952816250
• Device Catalogue Number: 39528-1625
• Device Lot Number: 17592913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1