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

Model Number 9311

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: promus element,mr,ous 4.00x28mm stent delivery system (sds) was returned for analysis.The device was returned inside a 0.071 guide catheter, with a haemostatic valve attached.The stent and balloon were visible distal to the distal tip of the guide catheter.Due to stent damage evident on the device, the device could not be removed proximally from the guide catheter.To facilitate the removal of the device from the guide catheter without further damage to the stent, the investigator cut the hypotube at a location 2mm distal to the distal strain relief.The sds is now in 2 pieces.The device was removed distally without issue.A visual and microscopic examination of the stent found proximal stent damage, with stent struts lifted and bunched proximally an distally.The undamaged stent outer diameter 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 damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.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 01oct2019.It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the severely calcified and mildly tortuous left anterior descending artery.A 4.00x28mm promus element drug-eluting stent was advanced but got stuck in the guide catheter.The procedure was completed with another of the same device.No patient complications were reported and the patients status is stable.However, returned device analysis revealed stent damage.

• 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: 9223926
• MDR Text Key: 166587881
• Report Number: 2134265-2019-12755
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Model Number: 9311
• Device Catalogue Number: 9311
• Device Lot Number: 0022440709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2018
• 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: 63 YR
• Patient Weight: 70