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

Model Number	9585
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9135453
• Report Number: 2134265-2019-11405
• Device Sequence Number: 11436511
• Product Code: NIQ
• UDI-Device Identifier: 08714729844785
• UDI-Public: 08714729844785
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/08/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR