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

Model Number H7493925124300

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the stent delivery system was returned for analysis.A visual examination of the stent found damage to the first proximal stent row with stent struts lifted and stretched in a proximal direction.The undamaged crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip found no signs of damage.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the device found no issues along the hypotube.A visual and tactile examination of the device found that there were no issues with the mid shaft, inner or outer polymer extrusion.No other issues were identified during the product analysis.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on analysis completed on 22mar2018.It was reported that the stent size was incorrect for the lesion.Vascular access was obtained via the femoral artery.The eccentric target lesion with a full thrombus was located in the mid to distal right coronary artery (rca).The lesion contained a bend between >45 and <90 degrees.The physician then decided to do direct stenting without thrombosuction.Subsequently, a 24mmx3.00mm promus premier¿ stent was advanced to treat the lesion.However, upon positioning the stent, the physician felt that the size of the stent was not appropriate for the lesion.The device was removed and a 28x3mm promus premier stent was deployed.The procedure was completed.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7426799
• MDR Text Key: 105344841
• Report Number: 2134265-2018-03000
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2018

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: 08/27/2019
• Device Model Number: H7493925124300
• Device Catalogue Number: 39251-2430
• Device Lot Number: 21088630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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
• Patient Age: 52 YR
• Patient Weight: 81