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

Catalog Number	1125225-15
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2018
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.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 similar incidents from this lot.The investigation determined that the reported failure to advance, stent dislodgement, foreign body in patient and subsequent treatment appear to be related to circumstances of the procedure.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 heavily calcified lesion in the diagonal.The 2.25x15mm rx xience alpine stent delivery system (sds) was advanced through previously deployed stents in the left anterior descending (lad) artery to the diagonal, but was unable to cross due to the anatomy.The sds was retracted; however, it was noted that the stent was not on the balloon.The dislodged stent was found inside one of the previously placed stents in the lad.The alpine sds was re-advanced and inflated to 20 atmospheres (atm) and able to deploy the dislodged stent inside of the previously placed stent.A 3.0x15mm nc balloon was inflated to nominal pressure to post-dilate the stent.Another 2.25x15mm alpine stent was successfully deployed in the target diagonal lesion.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: 7260399
• Report Number: 2024168-2018-00957
• Device Sequence Number: 19091749
• Product Code: NIQ
• UDI-Device Identifier: 08717648199073
• UDI-Public: 08717648199073
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: 11/02/2020
• Device Catalogue Number: 1125225-15
• Device Lot Number: 7101961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: Required Intervention
• Patient Age: 54 YR