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

Catalog Number	1145350-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary:the device was returned for analysis.The reported stent dislodgement was confirmed.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 identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified lesion resulting in the reported failure to advance.Additionally, interaction with the guiding catheter during retraction likely resulted in the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the right coronary artery.Following pre-dilatation, a 3.5x28mm xience alpine otw stent delivery system (sds) failed to cross due to the anatomy.The sds was pulled out and the stent dislodged on the wire.An attempt was made to snare the stent, but unable to retrieve.The patient was then transferred to (b)(6) medical center where another attempt to snare was performed.The stent was successfully snared and the patient is doing fine.No additional information was provided.

• Brand Name: XIENCE ALPINE OTW 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: 7236088
• Report Number: 2024168-2018-00766
• Device Sequence Number: 1176688
• Product Code: NIQ
• UDI-Device Identifier: 08717648200274
• UDI-Public: 08717648200274
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 02/01/2018

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: 10/03/2020
• Device Catalogue Number: 1145350-28
• Device Lot Number: 7092541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/02/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR