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

Model Number H7493925124300

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that foreign matter was found stuck on the protection hoop of the stent.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 24x3.00 promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, dust was found stuck on the protection hoop of the stent.The procedure was completed with this device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned for analysis.The hoop of the device was returned for analysis of the foreign material (fm) reported by the customer.Adhesive tape indicated the area of the fm which appeared to be a white fibre, 25mm in length, similar in appearance to a label strip used in manufacturing.The fibre was sent to the material characterisation laboratory for evaluation with a sample of a label material used at the (b)(4) site for comparison.An exact match of the fm was not determined; with the fourier transform infrared analysis (ftir) spectra suggesting the fm is cellulose based sample with an adhesive surface on one side.The stent delivery catheter was not returned for 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 foreign matter was found stuck on the protection hoop of the stent.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 24x3.00 promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, dust was found stuck on the protection hoop of the stent.The procedure was completed with this 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
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5305815
• MDR Text Key: 33731547
• Report Number: 2134265-2015-08839
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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: 10/14/2016
• Device Model Number: H7493925124300
• Device Catalogue Number: 39251-2430
• Device Lot Number: 18022081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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