MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1125350-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: only the stent was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as only the stent was returned dislodged.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or label.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified right coronary artery via radial access.A 3.5 x 18 mm xience alpine stent delivery system was being advanced to the lesion when there was resistance with the anatomy.As the device was being removed there was resistance with the guideliner and the stent implant dislodged.The stent was removed with a snare device through the wrist.A new access site was made at the groin and a 3.5 x 16 mm non-abbott stent was successfully implanted to complete the procedure.There was a clinically significant delay in the procedure due to the snaring of the stent and having to obtain a new access site.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6880276
• Report Number: 2024168-2017-07620
• Device Sequence Number: 718207
• Product Code: NIQ
• UDI-Device Identifier: 08717648199530
• UDI-Public: 08717648199530
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: 06/05/2020
• Device Catalogue Number: 1125350-18
• Device Lot Number: 7052941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/20/2017
• 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: 71 YR
• Patient Weight: 84