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	04/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported failure to advance the device was unable to 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 did not indicate a lot specific quality issue.As there were crimp marks on the tightly folded balloon between the markers suggesting the stent was originally positioned correctly and securely at the time of manufacture, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the stent delivery system (sds) was advanced, resistance was met with the moderately calcified anatomy, resulting in the reported failure to advance.As the device was retracted, interaction with the moderately calcified anatomy ultimately resulted in the reported stent dislodgement.Based on the information reviewed, there is no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 during advancement of the 2.5x15 mm xience alpine stent delivery system (sds), resistance was met with the pre-dilated, moderately calcified anatomy in the right coronary artery (rca).The sds was removed from the anatomy without resistance; however, once out, it was noted that the stent was not on the sds.The dislodged stent was found in the rca and was able to be deployed, using multiple balloon dilatation catheters, in the proximal rca.Additional pre-dilatation was performed in the mid rca and another 2.5x15 mm xience alpine sds was successfully deployed in the target lesion.There was no adverse patient sequela and no clinically significant delay in the procedure.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: 6561917
• Report Number: 2024168-2017-04088
• Device Sequence Number: 649900
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: (01)08717648199165(17)200202(10)7012341
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/11/2017

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: 02/02/2020
• Device Catalogue Number: 1125250-15
• Device Lot Number: 7012341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/11/2017
• 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: PROWATER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 113