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

Model Number 10663

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: a promus premier select ous mr 16 x 3.00 mm stent delivery system was returned for analysis.A visual examination of the stent found that stent struts from the most distal stent strut row were lifted from their crimped position.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred when the stent was caught in calcification during withdrawal attempts.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 microscopic examination of the tip showed signs of damage at the distal edge of the tip.Tip damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination of the hypotube found no issues with the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner extrusion found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 01-oct-2020.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 90% stenosed, 15x3.00mm, eccentric, de novo target lesion with a bend of >=90 degrees was located in the severely tortuous and mildly calcified left circumflex artery.After a 6f guide catheter and a non-boston scientific guide wire crossed the lesion, pre-dilation was performed with a balloon catheter resulting to 50% residual stenosis.A 16 x 3.00 promus premier select drug-eluting stent was advanced but failed to cross the lesion even after multiple attempts.The device was removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10723366
• MDR Text Key: 212721965
• Report Number: 2134265-2020-14054
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Model Number: 10663
• Device Catalogue Number: 10663
• Device Lot Number: 0024338414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• 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: GUIDEWIRE USED (BMW 014)
• Patient Age: 50 YR
• Patient Weight: 58