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

Catalog Number	1125225-18
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	10/18/2016
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.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that during the procedure to treat a moderately calcified lesion in the moderately tortuous proximal 1st obtuse marginal (om1) coronary artery, a 2.25x18 rx xience alpine stent delivery system (sds) was advanced toward the lesion.When attempting to cross the lesion, resistance was felt against the lesion, the sds failed to cross, and, while no force was applied, the stent dislodged proximally onto the sds.The dislodged stent was snared by an unspecified snare device and pulled back into the left main artery.An unspecified stent was then advanced and deployed in the left main, crushing the dislodged xience alpine stent against the non-diseased left main arterial wall, completely outside of the target lesion.The target lesion in the om1 was left untreated and will be addressed via medical management.While this issue caused a clinically significant delay, there were no adverse patient sequelae and the patient is reportedly doing well.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.Visual inspections were performed on the returned device.The stent dislodgement was confirmed.The failure to advance could not 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 of the reported lot did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6083446
• Report Number: 2024168-2016-07664
• Device Sequence Number: 611835
• Product Code: NIQ
• UDI-Device Identifier: 08717648199080
• UDI-Public: (01)08717648199080(17)190216(10)6012861
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 12/29/2016

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: 02/16/2019
• Device Catalogue Number: 1125225-18
• Device Lot Number: 6012861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 12/29/2016
• 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