MAUDE Adverse Event Report: ABBOTT VASCULAR RX VISION CORONARY STENT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Catalog Number	1007821-08
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid right coronary artery with heavy calcification and heavy tortuosity.A 2.0 x 08 mm mini vision stent delivery system (sds) was advanced; however failed to cross the lesion due to the patient anatomy.On removal of the sds without reported force, resistance with the lesion was met and the stent dislodged.Medical intervention was performed to remove the stent and a dissection was noted.An additional unspecified stent was used to treat the dissection.There was no reported adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 did not indicate a lot specific quality issue.The reported patient effect of dissection as listed in the multi-link vision rapid exchange (rx) and over the wire (otw) coronary stent systems (css), instructions for use (ifu) is a known patient effect that may be associated with coronary stenting.The investigation determined that the reported difficulties and subsequent treatments appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: RX VISION CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8927751
• Report Number: 2024168-2019-11128
• Device Sequence Number: 13965218
• Product Code: MAF
• UDI-Device Identifier: 08717648049378
• UDI-Public: 08717648049378
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• 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,Followup
• Report Date (Section B): 09/09/2019

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: 12/31/2020
• Device Catalogue Number: 1007821-08
• Device Lot Number: 8011041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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