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

Model Number 9552

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 12/23/2023

Event Type  malfunction  

Event Description

It was reported that catheter tip detachment occurred.A 28 x 2.50 promus premier drug-eluting stent was selected for use.However, when unpacked, the delivery shaft at the proximal end of the delivery system was kinked and an attempt to straighten it led to a fracture of the stent balloon shaft at the proximal end.The procedure went smoothly and completed with a different device.There were no patient injuries reported.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).

Manufacturer Narrative

E1: (b)(6).Device evaluated by mfr: promus premier ous mr 28 x 2.50mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hyotube identified that a break had occurred at the proximal end of the hypotube.The break was located at 148cm from bumper distal tip of device.The proximal section of the break, including the hub manifold was not returned.However, a microscopic examination of the break site in the hypotube identified no issues with the hypotube which could have contributed to break.A visual and tactile examination of the shaft polymer extrusion identified no damages.A microscopic examination of the crimped stent via scope found no evidence of stent damage.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.

Event Description

It was reported that catheter tip detachment occurred.A 28 x 2.50 promus premier drug-eluting stent was selected for use.However, when unpacked, the delivery shaft at the proximal end of the delivery system was kinked and an attempt to straighten it led to a fracture of the stent balloon shaft at the proximal end.The procedure went smoothly and completed with a different device.There were no patient injuries reported.It was further reported that shaft break occurred instead of tip detachment.The manifold will not be returning as it was missing.

Event Description

It was reported that catheter tip detachment occurred.A 28 x 2.50 promus premier drug-eluting stent was selected for use.However, when unpacked, the delivery shaft at the proximal end of the delivery system was kinked and an attempt to straighten it led to a fracture of the stent balloon shaft at the proximal end.The procedure went smoothly and completed with a different device.There were no patient injuries reported.It was further reported that shaft break occurred instead of tip detachment.The manifold will not be returning as it was missing.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).

• Brand Name: PROMUS PREMIER
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18556357
• MDR Text Key: 333401929
• Report Number: 2124215-2024-03041
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9552
• Device Catalogue Number: 9552
• Device Lot Number: 0031975920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• 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: 65 YR
• Patient Sex: Female