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

Model Number H7493925132220

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

It was reported that a foreign material was found on the stent.A 32mm x 2.25mm promus premier¿ stent was selected for the procedure.When the device was unpacked, it was noticed that "something like a fiber" was adhered to the stent.The device was not used and the procedure was completed using a different device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.The stent protector was not returned with the device for analysis.A visual examination of the crimped stent found no damage to the stent struts.However fibrous strands were caught on the stent struts along the entire length of the crimped stent.The material was light in colour and was caught on the stent struts.Scanning electron microscope (sem) and fourier transform infrared spectroscopy (ftir) analyses were performed on the sample and concluded that the material was synthetic in nature and possibly a polyester fibre.A comparison was performed to compare the stent foreign material (fm) with a cleanroom lab coat, similar to the type used in device manufacturing.Contrasting & similar comparisons could be made between the two samples however it cannot be determined where the foreign matter first became present.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 and tactile examination found no issues with the hypotube shaft profile.A visual and tactile examination found no issues with the shaft polymer extrusion profile.No other issues were identified during the product analysis.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 a foreign material was found on the stent.A 32mm x 2.25mm promus premier stent was selected for the procedure.When the device was unpacked, it was noticed that "something like a fiber" was adhered to the stent.The device was not used and the procedure was completed using a different device.No patient complications were reported and the patient's status was good.

• 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: 4239446
• MDR Text Key: 5011775
• Report Number: 2134265-2014-06747
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2015
• Device Model Number: H7493925132220
• Device Catalogue Number: 39251-3222
• Device Lot Number: 16847735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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