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

Model Number 10668

Device Problems Break (1069); Entrapment of Device (1212); Material Deformation (2976); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  Injury  

Event Description

It was reported that balloon failure to deflate, shaft break, and entrapment of device occurred requiring additional intervention.The target lesion was located in the left anterior descending (lad) artery.A 38 x 3.50 promus premier select drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stuck in the lesion.The physician tried to pull back the device, but the stent became distorted at the proximal end.The balloon was inflated and was unable to be deflated.During removal of the device, the shaft broke.The physician removed the broken part with a snare and another balloon catheter.The procedure was completed with another stent.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Media review evaluated by mfr.: the reported event of stent damage and catheter entrapment of device could be confirmed by the images provided as an undeployed, damaged stent is noted on a delivery system balloon.The proximal region of the delivery system is noted to be inside the guide catheter, and a bend is noted on the delivery system at the location of contact with the distal guide.Additionally, bunching of the stent is noted on its mid-section.As no flow contrast assessment is provided of the images it cannot be confirmed if any inflation/difficulty in deflation of the balloon occurred.It is likely that an interaction of the stent with the distal end of the guide catheter occurred during removal of the delivery system, and this led to the stent to be caught and damaged.H3 other text : media review.

Event Description

It was reported that balloon failure to deflate, shaft break, and entrapment of device occurred requiring additional intervention.The target lesion was located in the left anterior descending (lad) artery.A 38 x 3.50 promus premier select drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stuck in the lesion.The physician tried to pull back the device, but the stent became distorted at the proximal end.The balloon was inflated and was unable to be deflated.During removal of the device, the shaft broke.The physician removed the broken part with a snare and another balloon catheter.The procedure was completed with another stent.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis in two sections as a result of a break in the midshaft extrusion.The break was located approximately 12 cm proximal from the guidewire port.The entire distal extrusion was severely stretched.The detached distal section was stretched and measured 41.5 cm from the tip to the break in the midshaft.A visual examination of the crimped stent identified that the stent was pulled distally on the balloon.The stent was bunched at its proximal and distal ends.The undamaged stent od (outer diameter) was measured by a snap gauge and the result was within range of an acceptable 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 identified no damage.A visual and tactile examination of the hypotube shaft found multiple kinks.No other issues were identified during analysis.Media review evaluated by mfr.: the reported event of stent damage and catheter entrapment of device could be confirmed by the images provided as an undeployed, damaged stent was noted on a delivery system balloon.The proximal region of the delivery system was noted to be inside the guide catheter, and a bend was noted on the delivery system at the location of contact with the distal guide.Additionally, bunching of the stent was noted on its mid-section.As no flow contrast assessment was provided of the images it could not be confirmed if any inflation/difficulty in deflation of the balloon occurred.It is likely that an interaction of the stent with the distal end of the guide catheter occurred during removal of the delivery system, and this led to the stent to be caught and damaged.

Event Description

It was reported that balloon failure to deflate, shaft break, and entrapment of device occurred requiring additional intervention.The target lesion was located in the left anterior descending (lad) artery.A 38 x 3.50 promus premier select drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stuck in the lesion.The physician tried to pull back the device, but the stent became distorted at the proximal end.The balloon was inflated and was unable to be deflated.During removal of the device, the shaft broke.The physician removed the broken part with a snare and another balloon catheter.The procedure was completed with another stent.There were no patient complications reported and the patient status was stable.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16500142
• MDR Text Key: 310851680
• Report Number: 2124215-2023-09263
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2024
• Device Model Number: 10668
• Device Catalogue Number: 10668
• Device Lot Number: 0029317983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 03/16/2023; 05/24/2023
• Supplement Dates FDA Received: 04/03/2023; 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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 Outcome(s): Required Intervention