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

Model Number	H7493952828220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the circumflex artery.A 2.25x28mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was dislodged off the delivery system.The dislodged stent was retrieved using a snaring device.The procedure was successfully completed with implantation of more stents.No patient complications were reported and patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: a stent was returned for analysis with a snare device.The stent delivery system (sds) was not returned.A visual and microscopic examination of the crimped stent found that the stent had been separated from its sds and damaged.The stent was severely damaged and stretched along its entire length.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the circumflex artery.A 2.25x28mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was dislodged off the delivery system.The dislodged stent was retrieved using a snaring device.The procedure was successfully completed with implantation of more stents.No patient complications were reported and 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: 6503144
• Report Number: 2134265-2017-03942
• Device Sequence Number: 339979
• 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,Followup
• Report Date (Section B): 04/05/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 05/22/2017
• 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
• Patient Age: 60 YR