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

Model Number	H7493952828220
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the direction for use states: if unusual resistance is felt at any time during lesion access before stent implantation, the stent delivery system and the guide catheter should be removed as a single unit.Do not attempt to pull an unexpanded stent back into the guide catheter, as stent or coating damage.(b)(4).
Event or Problem Description
It was reported that removal difficulties were encountered and stent dislodgement occurred.After a guide catheter was placed, a 2.25x28mm promus premier¿ drug eluting stent was introduced to treat the lesion.However, it was noted on the exit of the catheter, the stent did not ¿look¿ correct.At some point, the stent would not advance, and the physician attempted to pull the stent back into the guide catheter.However, the device failed to move.After continually trying, the stent was detached from the balloon and stent delivery system (sds).The sds was removed and a snare was introduced.The detached stent was snared back into the guide catheter and the device was removed.The procedure was completed with a different device.No further patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6497239
• Report Number: 2134265-2017-03638
• Device Sequence Number: 13609944
• Product Code: NIQ
• UDI-Device Identifier: 08714729844884
• UDI-Public: (01)08714729844884(17)20171114(10)0019303355
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 03/28/2017

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 Expiration Date: 11/14/2017
• Device Model Number: H7493952828220
• Device Catalogue Number: 39528-2822
• Device Lot Number: 0019303355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/17/2017
• 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