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

Catalog Number	1125250-15
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2016
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.Guide wire: versaturn, sion blue.Guide catheter: hyperion jr3.5, pb 3.5.(b)(4).The device was not returned for analysis.It was reported force was applied in the attempts to remove the device.The xience alpine everolimus eluting coronary stent system, instructions for use states: should unusual resistance be felt at any time when withdrawing the stent towards the guiding catheter, the stent delivery system and the guiding catheter should be removed as a single unit.Applying excessive force to the delivery system can potentially result in loss of or damage to the stent and / or delivery system components.The investigation determined an interaction with the previously deployed stent contributed to the resistance during advancement and the stent becoming caught on the implanted stent.Force applied as resistance was encountered during retraction would have resulted in the stent dislodging.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 of the reported lot did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a concentric de novo lesion in the moderately tortuous, heavily calcified, 90% stenosed mid left anterior descending (lad) coronary artery.A 2.5 x 15 mm xience alpine stent delivery system (sds) was selected for the procedure.The sds was advanced to a previously implanted non-abbott stent, met resistance and would not cross.While attempting to remove the sds from the anatomy, the stent implant become stuck in the previously implanted non-abbott stent.Force was applied to the sds in order to remove the sds from the anatomy.Once the sds was out of the anatomy, the stent implant was found to be dislodged from the balloon and located in the anatomy.Attempts to retrieve the stent implant failed and it remained lodged in the previously implanted non-abbott stent implant.The patient refused to have the dislodged stent implant removed surgically.The patient was observed in the hospital for a week and then was discharged on a regimen of aspirin, effient and eliquis.No additional information 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: 6223036
• Report Number: 2024168-2017-00067
• Device Sequence Number: 376228
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: (01)08717648199165(17)181124(10)5111741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

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: 11/24/2018
• Device Catalogue Number: 1125250-15
• Device Lot Number: 5111741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2016
• Initial Report FDA Received Date: 01/04/2017
• 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: SEE H10 FOR CONCOMITANT MEDICAL DEVICES
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR