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

Model Number 9554

Device Problems Difficult or Delayed Positioning (1157); Material Rupture (1546)

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

Event Date 05/15/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: promus premier ous mr 38 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts on the proximal end were lifted and pulled in a distal direction.The undamaged stent outer diameter was measured and the result was within 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 showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.The inflation device was verified to rated burst pressure(rbp) before and after testing.A test 0.014" guidewire was loaded through the device.The balloon was inflted to rbp and deflated in 7 seconds.The stent was deployed without issue.No other issues were identified during analysis.

Event Description

It was reported that balloon rupture occurred.The 38mm x 3.20mm stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.Following pre-dilatation, a 38 x 3.00 promus premier drug-eluting stent was advanced to treat the lesion.However, during deployment, the stent did not fully expand and could not dilate the lesion.Furthermore, angiography showed that the balloon was not completely deployed after pressure was applied.The physician stated that the difficulty deploying the stent might have been caused by a ruptured balloon.The procedure was completed with the original device.There were no complications 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: 12278789
• MDR Text Key: 265141859
• Report Number: 2134265-2021-09750
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0026356694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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: 56 YR
• Patient Weight: 60