MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1550350-33
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.Visual inspections were performed on the returned device.The reported resistance met during advancement could not be replicated in a testing environment as it was based on operational circumstances.The reported separation was confirmed.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 difficulties appear to be related to challenging anatomical conditions.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal left anterior descending (lad) artery with heavy calcification and moderate tortuosity.It was noted that a previously unspecified stent in the lad, was implanted three days prior.The patient presented to the hospital with angina.A 3.5 x 33 mm xience sierra stent delivery system (sds) was advanced with resistance due to the heavy calcification.Minimal force was applied and prior to crossing the target lesion, the proximal shaft became separated, but remained held together on the guide wire.The sds was removed with the unspecified guide wire as a single unit.Two additional devices failed to cross and the procedure was aborted without the target lesion being treated.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8942537
• Report Number: 2024168-2019-11307
• Device Sequence Number: 11300568
• Product Code: NIQ
• UDI-Device Identifier: 08717648227455
• UDI-Public: 08717648227455
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2020
• Device Catalogue Number: 1550350-33
• Device Lot Number: 9050842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1