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

Catalog Number	1125300-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
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.(b)(4).The device was not returned for analysis.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent use error as it is likely that as the sds was advanced resistance was met with the heavily calcified anatomy resulting in the reported physical resistance.As the device was removed and re-advanced, then once again removed and re-advanced (against the instructions for use) interaction with the anatomy and/or other devices resulted in the reported stent dislodgement.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.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 lesion in the heavily calcified, proximal left anterior descending artery.Balloon dilatation was performed numerous times; however, the 3.0 x 8 mm xience alpine stent delivery system (sds) would not cross.The device was removed and additional balloon dilatation was performed and a second attempt was made to cross with the same sds; however, it would not cross.The device was removed and additional dilatation was performed and a third attempt was made to cross to the lesion and this time it reached the lesion; however, during positioning of the stent delivery system in the lesion, the stent implant dislodged from the balloon was located partially in the lesion.A balloon catheter was advanced and the stent was deployed where it dislodged; however, not fully covering the lesion.Another 3.0 x 8 mm xience alpine sds was used successfully to treat the remaining lesion.No adverse patient effects or clinically significant delay in the procedure were 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: 6815251
• Report Number: 2024168-2017-06887
• Device Sequence Number: 130504
• Product Code: NIQ
• UDI-Device Identifier: 08717648199325
• UDI-Public: 08717648199325
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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: 09/26/2019
• Device Catalogue Number: 1125300-08
• Device Lot Number: 6091941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/23/2017
• 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