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

Model Number H7493925108350

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.An 8 x 3.50 promus premier¿ drug-eluting stent was selected to treat the target lesion.However, when the device was at the level with a non-bsc guide, the hypotube ruptured.

Manufacturer Narrative

Device is a combination product.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual and tactile examination found multiple kinking on the hypotube shaft and the shaft itself was broken at the point of a severe kink.The hypotube broke 186mm distal from the strain relief.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 stent found no issues with its profile.A visual and tactile examination of the outer found a shaft kink and minor damage between the port bond skive and 50m distal from the port bond skive.This type of damage is likely to have been caused by excessive tensile forces being applied to the delivery system.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 was unable to be determined.(b)(4).

Event Description

It was reported that shaft break occurred.An 8 x 3.50 promus premier drug-eluting stent was selected to treat the target lesion.However, when the device was at the level with a non-bsc guide, the hypotube ruptured.

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4355361
• MDR Text Key: 5203721
• Report Number: 2134265-2014-08018
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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: 10/10/2015
• Device Model Number: H7493925108350
• Device Catalogue Number: 39251-0835
• Device Lot Number: 16973345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2014
• 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
• Treatment: KT GUIDE