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

Model Number 9551

Device Problems Positioning Failure (1158); Entrapment of Device (1212); Difficult to Advance (2920)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that device entrapment occurred.Vascular access was obtained via the radial artery.The 75% stenosed concentric, de novo target lesion was located in the mildly tortuous and mildly calcified right coronary artery.Following pre-dilation with multiple, different balloon sizes, 50% stenosis remained.A 24 x 3.00mm promus premier drug-eluting stent was advanced, however, resistance was encountered despite having proper support from the guiding catheter.During deployment, the proximal part of the stent did not open and the stent become stuck over the guide wire.Both the guide wire and stent were removed from the patient.The procedure was completed with another pt2 guide wire and a 24x3.00mm non-boston scientific stent.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

(b3) date of event updated from (b)(6) 2022.

Event Description

It was reported that device entrapment occurred.Vascular access was obtained via the radial artery.The 75% stenosed concentric, de novo target lesion was located in the mildly tortuous and mildly calcified right coronary artery.Following pre-dilation with multiple, different balloon sizes, 50% stenosis remained.A 24 x 3.00mm promus premier drug-eluting stent was advanced, however, resistance was encountered despite having proper support from the guiding catheter.During deployment, the proximal part of the stent did not open and the stent become stuck over the guide wire.Both the guide wire and stent were removed from the patient.The procedure was completed with another pt2 guide wire and a 24x3.00mm non-boston scientific stent.No patient complications were reported and the patient status was stable.

• 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: 13766444
• MDR Text Key: 287354506
• Report Number: 2134265-2022-02660
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0028020894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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
• Treatment: RUNTHROUGH PTCA GUIDEWIRE; RUNTHROUGH PTCA GUIDEWIRE
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 90 KG