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

Model Number 9549

Device Problems Positioning Failure (1158); Material Rupture (1546)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The patient underwent coronary artery bypass grafting and percutaneous coronary intervention under local anesthesia.The target lesion was located in obtuse marginal branch.A 2.25 x 16 promus premier drug-eluting stent was advanced for treatment.However, after the stent was placed, the stent failed to deploy.The device was withdrawn, and it was noticed that the balloon was broken and was scrapped.The procedure was completed with a different device, and it was noted that the treatment time was delayed.No further patient complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Device/media analysis: no device was returned for analysis.The device has been discarded by the end customer can not be returned.However, attached to gfe tw 16853329 is a video clip capturing a pinhole leak in the balloon.The pinhole is located over the proximal edge of the proximal markerband.The video captures the leak when an attempt is made to inflate the balloon, outside the patient.The stent appears crimped on the balloon and could not deploy from the balloon due to the leak in the balloon.

Event Description

It was reported that balloon rupture occurred.The patient underwent coronary artery bypass grafting and percutaneous coronary intervention under local anesthesia.The target lesion was located in obtuse marginal branch.A 2.25 x 16 promus premier drug-eluting stent was advanced for treatment.However, after the stent was placed, the stent failed to deploy.The device was withdrawn, and it was noticed that the balloon was broken and was scrapped.The procedure was completed with a different device, and it was noted that the treatment time was delayed.No further patient complications were reported.

• 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: 17370254
• MDR Text Key: 319503839
• Report Number: 2124215-2023-38353
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: 9549
• Device Catalogue Number: 9549
• Device Lot Number: 0028953503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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 Age: 59 YR
• Patient Sex: Male