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

Model Number 9313

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device is a combination product.Device evaluated by mfr: promus element ,mr,ous 3.00 x 32 mm stent delivery system was returned for analysis with stent protector and mandrel attached and a kink was noted in the product mandrel and stent section 30mm proximal of the distal tip.Mandrel and protector removed easily.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the mid stent region were noted to be slightly lifted from their crimped position.The undamaged crimped stent outer diameter was measured and the result was within max 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 damage.A visual and tactile examination of the hypotube shaft found a break in the hypotube shaft at 263mm distal to the distal end of the strain relief as well as multiple kinks.A visual and tactile examination of the outer and mid-shaft section found a shaft polymer extrusion kink in the midshaft section measured at 278mm from the distal end of the tip.A 0.014" test guidewire was successfully inserted tough the distal tip and exited at the guidewire exchange port.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 19jun2020.It was reported that shaft kink occurred and tracking difficulties were encountered.Vascular access was obtained via the right femoral artery.The 80-90% stenosed, 28mmx3mm, concentric, de novo target lesion with a lesion bend between 45 and 90 degrees and was located in the severely tortuous and moderately calcified right coronary artery.After engaging the lesion with a non-bsc guide catheter and a guide wire, a 1.5x15mm maverick balloon was used for pre-dilatation.A 3.00x32mm promus element stent was advanced but failed to track the lesion.An additional wire was advanced for better support but the device still could not cros the lesion.Upon maneuvering the device, the hypotube became kinked and the damaged stent was removed from the patient's body.The procedure was completed with another 3x3.2mm promus element with 2 wires.The result was good with timi 3 flow.No patient complications were reported and the patient was stable.However, returned device analysis revealed stent damaged.

• Brand Name: PROMUS ELEMENT
• 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: 10259014
• MDR Text Key: 198376361
• Report Number: 2134265-2020-08435
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2020
• Device Model Number: 9313
• Device Catalogue Number: 9313
• Device Lot Number: 0022886851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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: 67 YR