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

Model Number 9585

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent explantation occurred.The target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery.A 2.75 x 20 mm promus premier drug-eluting stent was deployed to treat the lesion.However, the stent stuck to the post dilatation balloon and came out of the body after deployment.The procedure was completed with a new promus stent.There were no further patient complications reported.

Manufacturer Narrative

Bsc aware date corrected from 08sep2019 to 07sep2019.Device is a combination product.Device evaluated by mfr.: a damaged detached stent was returned for analysis without the stent delivery system.The entire length of the stent was stretched and damaged.

Event Description

It was reported that stent explantation occurred.The target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery.A 2.75x20mm promus premier drug-eluting stent was deployed to treat the lesion.However, the stent stuck to the post dilatation balloon and came out of the body after deployment.The procedure was completed with a new promus stent.There were no further patient complications reported.It was further reported that the procedure was completed with another of the same device and the patient's 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: 9135453
• MDR Text Key: 161365344
• Report Number: 2134265-2019-11405
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844785
• UDI-Public: 08714729844785
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9585
• Device Catalogue Number: 9585
• Device Lot Number: 0022339347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR