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

Model Number 10667

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr.: a promus premier select ous mr 32 x 3.00 mm stent delivery system was returned for analysis.The device was returned with product mandrel stuck in the wire lumen of the device which could not be removed.The device was placed in bath to soak at 37 degrees celsius.After soaking the mandrel was removed without issues.A visual examination of the stent found that stent struts from the mid-section to the distal end of the stent (except the last 3 most distal stent strut rows) were squashed and misaligned.The undamaged crimped stent outer diameter was measured and the result is within maximum crimped stent profile measurement.Stent damage most likely occurred when the stent met restriction of a calcified lesion.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 no signs of damage.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 85% stenosed, 32mm in length, 3.00 vessel diameter target lesion containing a >=90 degrees bend was located in the severely tortuous and non-calcified right coronary artery.A 32 x 3.00 promus premier select drug-eluting stent (des) was advanced but could not navigate through the lesion after multiple attempts.A 32 x 2.75 promus premier select des was then used but still could not navigate through the lesion after multiple attempts.The procedure was completed with a different device.No patient complications were reported and the patient 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: 10722374
• MDR Text Key: 212698794
• Report Number: 2134265-2020-14141
• 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: 03/08/2021
• Device Model Number: 10667
• Device Catalogue Number: 10667
• Device Lot Number: 0023501096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2019
• 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