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

Model Number 9554

Device Problem Difficult to Remove (1528)

Patient Problem Vasoconstriction (2126)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that removal difficulty occurred and patient experienced vessel spasm.The target lesion was located in the distal left circumflex artery.A 38 x 4.00mm promus premier drug-eluting stent was advanced but failed to cross the lesion.When the device was removed, resistance was encountered as the patient experienced vessel spasm so the stent was deployed instead in the brachial artery.No further patient complications were reported and patient status was stable.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: promus premier ous mr 38 x 4.00mm stent delivery system was returned for analysis.No stent was returned with the device.The balloon cones showed signs of positive pressure applied.A visual and microscopic examination of the bumper tip found no issues.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues with the shaft polymer extrusion.A recommended 0.0140 inch guidewire successfully loaded through the tip.The device was inflated to 16atm balloon inflated with no issues noted.A vacuum was pulled and the balloon deflated in 15 seconds which is within specification.The inflation device was verified before and after use.No other issues were identified during the product analysis.

Event Description

It was reported that removal difficulty occurred and patient experienced vessel spasm.The target lesion was located in the distal left circumflex artery.A 38 x 4.00mm promus premier drug-eluting stent was advanced but failed to cross the lesion.When the device was removed, resistance was encountered as the patient experienced vessel spasm so the stent was deployed instead in the brachial artery.No further patient complications were reported and 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
• MDR Report Key: 8866076
• MDR Text Key: 153433745
• Report Number: 2134265-2019-09013
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2021
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0023385321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 74