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

Model Number 9548

Device Problems Failure to Advance (2524); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The 12mmx3.5mm, 80% stenosed target lesion was located in moderately tortuous and calcified left anterior descending (lad) artery.A 12 x 3.50 promus premier stent was advanced for treatment.However, the device failed to cross the lesion and noted that the tip of the stent was lifted.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

B5 - describe event or problem has been updated.H6 - device codes: initially reported with material deformation (a0406) and has now been updated to material integrity problem (a04).

Event Description

It was reported that stent damage occurred.The 12mmx3.5mm, 80% stenosed target lesion was located in moderately tortuous and calcified left anterior descending (lad) artery.A 12 x 3.50 promus premier stent was advanced for treatment.However, the device failed to cross the lesion and noted that the tip of the stent was lifted.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the tip of the catheter was lifted up and not the tip of the stent as previously reported.The device was completely removed from the patients body in normal method.

Event Description

It was reported that stent damage occurred.The 12mmx3.5mm, 80% stenosed target lesion was located in moderately tortuous and calcified left anterior descending (lad) artery.A 12 x 3.50 promus premier stent was advanced for treatment.However, the device failed to cross the lesion and noted that the tip of the stent was lifted.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the tip of the catheter was lifted up and not the tip of the stent as previously reported.The device was completely removed from the patients body in normal method.

Manufacturer Narrative

Device evaluated by mfr.: the promus premier ous mr 12 x 3.50mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Flaring was identified at the distal end of the stent.The undamaged stent od (outer diameter) was measured, and was inside the maximum crimped stent profile specification.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 distal tip found no issues.A visual and tactile examination of the hypotube identified kinks located at at 65cm and 67.5cm distal from the strain relief.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen identified a kink located kinked at 5.4cm distal to port.No other issues were noted.

• Brand Name: PROMUS PREMIER
• 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: 13692859
• MDR Text Key: 286751891
• Report Number: 2134265-2022-02578
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0028020410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 77 KG