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

Catalog Number	1550250-33
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
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.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the previously implanted stent resulting in the reported failure.Manipulation of the device resulted in the subsequent stent dislodgement.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 performed to treat an occluded lesion in the mid right coronary artery (rca) with heavy tortuosity and no calcification.The vessel diameter was 5mm.A 4.00 x 38 mm xience sierra stent was successfully deployed.The stent was not post-dilated, but was noted to be undersized for the lesion.Post deployment, the vessel distal to the stent could be visualized and further occlusion was noted.Therefore, a 2.50 x 33 mm xience sierra sds was attempted to be advanced distally; however, met resistance and became stuck with the deployed 4.00 x 38 mm stent.Difficulty removing the 2.50 x 33 mm xience sierra sds was felt and force was applied.The stent dislodged.A snare device was used unsuccessfully to try and retrieve the stent.As the lesion distal to the deployed stent remained occluded, further attempts at snaring the dislodged stent were not made and the patient underwent bypass surgery for the rca.The dislodged stent was removed during the surgical procedure.There was no reported damage to the deployed stent and this was not explanted.The patient was reported to be doing well.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 7993390
• Report Number: 2024168-2018-08097
• Device Sequence Number: 201842
• Product Code: NIQ
• UDI-Device Identifier: 08717648227134
• UDI-Public: 08717648227134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: 06/13/2019
• Device Catalogue Number: 1550250-33
• Device Lot Number: 8060541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/22/2018
• 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: Hospitalization; Required Intervention; Disability