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

Model Number H7493952816350

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is a combination product.(b)(4).

Event Description

It was reported that a foreign matter was found inside the sterile package.A 3.50x16mm promus premier¿ drug-eluting stent was selected for use.However, upon opening the package and ¿the kit¿ of the stent, debris was noted on ¿it¿.The device was not used and the procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: promus premier, us, mr 3.50 x 16mm stent delivery system (sds) was returned for analysis.A visual and tactile examination found a dry foreign matter (fm) residue (white and cloudy) 1.5cm distal from the hypobond, in patches along the midshaft, inner/ outer lumen and continued to the distal tip.The fm was non removal and could be seen with a naked eye.There was also a hypotube kink 4mm distal of hypobond.Initial analysis of the device thought that the fm residue was possibly from bioslide solution.Bioslide solution is a hydrophilic coating that is applied to the promus premier shaft to improve lubricity of the device to aid deliverability.Fourier transform infrared analysis was carried out to identify the fm residue.The testing concluded that the fm residue was not bioslide solution.Analysis could not fully confirm the origin of this dry fm residue.A visual and tactile examination found damage to the tip; stretched and jagged at the edge.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 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.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 a foreign matter was found inside the sterile package.A 3.50x16mm promus premier drug-eluting stent was selected for use.However, upon opening the package and "the kit" of the stent, debris was noted on "it".The device was not used and the procedure was completed with a different device.No patient complications were reported.

• 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: 5598994
• MDR Text Key: 43361904
• Report Number: 2134265-2016-03343
• 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: Occupational Therapist
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

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: 04/07/2017
• Device Model Number: H7493952816350
• Device Catalogue Number: 39528-1635
• Device Lot Number: 18524906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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