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

Model Number 10662

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by mfr: p select ous mr 12 x 3.50mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.There was slight lifting of the stent struts in the most proximal and most distal strut rows.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.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 bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found a single kink located in the strain relief section, 555mm distal to the distal end of the strain relief.A visual examination of the outer and inner lumen and mid-shaft section 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 16sep2020.It was reported that crossing difficulty was encountered.Vascular access obtained via femoral artery.The 90% stenosed, 12 x 3.5mm, concentric, de novo target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 12x3.50mm promus premier select drug-eluting stent was advanced but failed to cross the lesion.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: 10638073
• MDR Text Key: 210080163
• Report Number: 2134265-2020-13093
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: 10662
• Device Catalogue Number: 10662
• Device Lot Number: 0024154357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2019
• 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
• Patient Age: 45 YR