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

Catalog Number	1125225-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2017
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).Evaluation summary: the device was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported balloon material rupture was unable to be confirmed, however there was a noted tear on the inner member.The reported difficulty to position was unable to be confirmed.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the device was advanced on the guide wire a coagulation of blood and contrast on the guide wire resulted in the reported difficulty to position.As the device was removed, then re-inserted onto the guide wire, an interaction with the guide wire resulted in the noted tear in the inner member thus as the device was inflated resulted in the reported material rupture/noted inner member leak.Manipulation of the compromised device and/or interaction with the 90% stenosed and heavily calcified concentric lesion resulted in the reported stent dislodgement.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.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged when retracting the undeployed stent back into the guiding catheter.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 90% stenosed and heavily calcified lesion in the mid left anterior descending artery.Following pre-dilatation of the lesion several times, a 2.25x23mm xience alpine stent delivery system (sds) was advanced over a non-abbott guide wire.Resistance was felt between the sds and guide wire.The sds was removed off the guide wire and the guide wire was re-inserted into the guide wire lumen of the sds.This time the sds advanced over the guide wire smoothly.The sds reached the target lesion and was pressurized to 3 atmospheres (atms); however, the needle gauge on the inflation device dropped to 0 atms.The sds was removed from the anatomy and it was confirmed that the stent dislodged and remained at the lesion site.A 2.0x12mm nc trek balloon dilatation catheter was advanced to the stent and the stent was deployed successfully at the intended site.There was no clinically significant delay in the procedure and no adverse patient effects.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: 6501213
• Report Number: 2024168-2017-03289
• Device Sequence Number: 10934594
• Product Code: NIQ
• UDI-Device Identifier: 08717648199097
• UDI-Public: (01)08717648199097(17)191115(10)6110741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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: 11/15/2019
• Device Catalogue Number: 1125225-23
• Device Lot Number: 6110741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: SION BLUE
• Outcome Attributed to Adverse Event: Required Intervention